Public record examples from openFDA
These examples are public records used only to illustrate the research workflow. They are not TrueMedDevice customers or endorsers.
Recent openFDA 510(k) records under product code FRN, Pump, Infusion, included the following examples as of the 2026-06-03 query.
| K-number | Device name | Applicant | Decision date | Type |
|---|---|---|---|---|
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | 2026-01-28 | Traditional |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | 2025-07-28 | Traditional |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2025-07-28 | Traditional |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025-05-28 | Traditional |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025-04-25 | Traditional |
| K242114 | Plum Solo Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | Traditional |
| K242115 | Plum Duo Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | Traditional |
| K250357 | RemunityPRO Pump for Remodulin (treprostinil) Injection | Deka Research & Development Corp. | 2025-03-11 | Special |
Step 1: Define the pump category
FDA describes infusion pumps as devices that deliver fluids such as nutrients and medications into a patient's body in controlled amounts. FDA also notes many pump types: large-volume, patient-controlled analgesia, elastomeric, syringe, enteral, insulin, stationary, ambulatory, portable, and wearable pumps.
This matters because 'infusion pump' is not enough for a predicate search. Product category, intended use, environment, controls, drug library, alarms, connectivity, accessories, and software features can all change the review questions.
Step 2: Find candidate product codes
Start with FDA Product Classification and openFDA classification records. In openFDA, product code FRN maps to Pump, Infusion, regulation 880.5725, device class 2.
But do not stop there. openFDA also shows pump-related records under other product codes, including QFG for alternate controller enabled insulin infusion pumps. Other pump accessories and specialized pump systems may have different classifications.
Step 3: Pull public 510(k) records
Search by candidate product code and product terms. For FRN, the openFDA 510(k) API showed 848 records on 2026-06-03, with recent records in 2025 and 2026.
A reviewer should capture the K-number, applicant, device name, decision date, clearance type, 510(k) Summary or Statement, and product-code mapping. Do not use a public 510(k) record as a shortcut conclusion. Use it as a structured input.
Step 4: Compare intended use and technology
A source-backed shortlist should compare intended use, target users, use environment, pump control method, drug library or dose-error-reduction features, remote monitoring, interoperability, alarm strategy, accessories, and software differences.
A recent public record may be useful to review, but recency alone does not make it a predicate. Similarity depends on intended use and technological characteristics reviewed by qualified RA/QA professionals or consultants.
Step 5: Add public safety-history themes
FDA's infusion pump page highlights historical safety concerns including over-infusion, under-infusion, missed treatments, delayed therapy, software defects, user interface issues, and mechanical or electrical failures.
FDA's Medical Device Reporting page also warns about limitations. Passive reports cannot determine incidence, prevalence, or causation by themselves. Use these records as review inputs, not as statistical conclusions.
Workload and cost framing
For an infusion pump category review, a careful founder or analyst can easily spend 12 to 30 hours building a source-backed shortlist: product-code search, 510(k) records, summaries, device comparisons, safety-history scan, and source ledger.
The useful deliverable is not a quick summary. It is a reviewer-ready packet with source verification, product-code discipline, comparison boundaries, and open questions.
Source ledger
What it can tell you
FDA's definition of infusion pumps, common pump types, safety-history context, and reported problem themes.
What it cannot decide
Predicate suitability, safety conclusions, effectiveness conclusions, or product-specific regulatory decisions.
What it can tell you
FDA's historical safety concerns, including design, engineering, software, safety assurance case, validation, servicing, maintenance, and use.
What it cannot decide
Whether a specific design satisfies FDA expectations.
What it can tell you
Public classification record for product code FRN: Pump, Infusion; regulation 880.5725; device class 2.
What it cannot decide
Whether FRN is the right product code for a specific pump.
What it can tell you
Recent public 510(k) records under product code FRN, including K-numbers, applicant, device name, decision date, and clearance type.
What it cannot decide
Whether any listed record is a valid predicate for a new product.
What it can tell you
Recent public records for alternate controller enabled insulin infusion pumps, showing that pump-related products may sit in different product-code categories.
What it cannot decide
Whether an insulin pump, alternate controller enabled pump, or accessory belongs to any specific product code.
What it can tell you
FDA's explanation of Medical Device Reporting and MAUDE limitations; MDR reports are passive surveillance reports and not proof of causation.
What it cannot decide
Incidence, prevalence, or causality from MAUDE alone.
Frequently asked questions
Can a recent 510(k)-cleared infusion pump be my predicate?
Maybe, but the public record does not decide that. A recent 510(k)-cleared pump can be a candidate comparator. Predicate suitability depends on intended use, technological characteristics, labeling, and the manufacturer's submission strategy, reviewed by qualified RA/QA professionals or consultants.
Is product code FRN always the right infusion pump code?
No. openFDA shows FRN for Pump, Infusion, but pump-related products can appear under other product codes, including QFG for alternate controller enabled insulin infusion pumps. The product-code search should start broad and narrow only after product mapping.
Can MAUDE reports tell me the failure rate of an infusion pump?
No. FDA explains that Medical Device Reporting and MAUDE are passive surveillance sources with limitations. They can surface review themes, but they cannot determine incidence, prevalence, or causation by themselves.
What does TrueMedDevice prepare for this use case?
A source-backed infusion pump evidence packet: candidate product codes, public 510(k) shortlist with K-numbers and dates, similar-device comparison points, safety-history review themes, source links, open questions, and a reviewer-ready decision-support structure.
Need a source-backed infusion pump evidence packet?
Send the pump family and target use. We can scope a Product Evidence Pack with candidate public records, product-code mapping, safety-history themes, and open questions for qualified review.