FDA product code · General Hospital
FRNPump, Infusion
Product code FRN covers Pump, Infusion, a Class II device regulated under 21 CFR 880.5725. FDA has cleared 849 devices in this code, 2 of them in the last 12 months. Median review time across the 849 most recent decisions is 83 days. openFDA lists 718 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5725
- Review panel
- General Hospital
- Clearances
- 849
What is happening in FRN right now?
FRN (Pump, Infusion) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2723-2026, Z-2724-2026, Z-2223-2026, Z-2224-2026, Z-2311-2026). 1 first-time filer in the last 12 months, Deka R&D Corp (K253703). The code is crowded, scoring 75 of 100 — 256 companies hold a clearance here and 2 arrived in the last 12 months (FRN:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2723-2026, Z-2724-2026, Z-2223-2026, Z-2224-2026, Z-2311-2026 |
| New entrant | Worth knowing | K253703 |
| Crowding | Context | FRN:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FRN?
FDA has cleared 849 devices under product code FRN since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | |
| K242115 | Plum Duo Precision IV Pump | Icu Medical, Inc. | |
| K242114 | Plum Solo Precision IV Pump | Icu Medical, Inc. | |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. |
How long does FDA review take for FRN?
The median FDA review time for FRN is 83 days, measured across the 849 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FRN?
openFDA lists 718 recall records against product code FRN. A recall record covers one firm's corrective action and may span many device lots.
Z-2723-2026Open, ClassifiedICU Medical, Inc.
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Z-2724-2026Open, ClassifiedICU Medical, Inc.
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Z-2223-2026Open, ClassifiedFresenius Kabi USA, LLC
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Z-2224-2026Open, ClassifiedFresenius Kabi USA, LLC
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Z-2311-2026Open, ClassifiedICU Medical, Inc.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Showing the 5 most recently initiated of 718. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FRN?
MAUDE holds 266,469 adverse-event reports naming product code FRN, 33,398 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FRN unusual?
Every month with enough history behind it falls inside FRN's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 8,731 | Insufficient history | No expected range — too little history | |
| 17,447 | Insufficient history | No expected range — too little history | |
| 19,945 | Insufficient history | No expected range — too little history | |
| 16,854 | Insufficient history | No expected range — too little history | |
| 15,698 | Insufficient history | No expected range — too little history | |
| 18,197 | Insufficient history | No expected range — too little history | |
| 14,396 | Insufficient history | No expected range — too little history | |
| 17,309 | Insufficient history | No expected range — too little history | |
| 12,042 | Insufficient history | No expected range — too little history | |
| 4,467 | Insufficient history | No expected range — too little history | |
| 6,975 | Insufficient history | No expected range — too little history | |
| 5,408 | Insufficient history | No expected range — too little history | |
| 5,052 | Insufficient history | No expected range — too little history | |
| 4,680 | Insufficient history | No expected range — too little history | |
| 4,627 | Insufficient history | No expected range — too little history | |
| 4,461 | Insufficient history | No expected range — too little history | |
| 3,672 | Insufficient history | No expected range — too little history | |
| 4,352 | Insufficient history | No expected range — too little history | |
| 5,000 | Insufficient history | No expected range — too little history | |
| 4,818 | Insufficient history | No expected range — too little history | |
| 4,219 | Insufficient history | No expected range — too little history | |
| 3,563 | 2,236–6,022 | Within expected (2,236–6,022) | |
| 3,694 | 1,756–5,202 | Within expected (1,756–5,202) | |
| 3,848 | 2,681–5,211 | Within expected (2,681–5,211) | |
| 4,496 | 2,969–5,118 | Within expected (2,969–5,118) | |
| 4,230 | 3,069–4,751 | Within expected (3,069–4,751) | |
| 4,320 | 3,276–5,043 | Within expected (3,276–5,043) | |
| 5,124 | 5,378–7,813 | Below expected (5,378–7,813) | |
| 4,649 | 3,595–5,686 | Within expected (3,595–5,686) | |
| 4,894 | 3,968–5,830 | Within expected (3,968–5,830) | |
| 4,986 | 3,943–5,797 | Within expected (3,943–5,797) | |
| 4,025 | 3,602–5,243 | Within expected (3,602–5,243) | |
| 3,864 | 3,864–5,650 | Within expected (3,864–5,650) | |
| 3,623 | 3,958–6,393 | Below expected (3,958–6,393) | |
| 4,026 | 2,619–5,372 | Within expected (2,619–5,372) | |
| 4,735 | 2,871–5,898 | Within expected (2,871–5,898) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in FRN.
Who has entered FRN in the last year?
One company filed in FRN for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Deka R&D Corp | K253703 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FRN?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FRN?
Across the 849 most recent decisions, these applicants filed most often in FRN.
| Applicant | Recent clearances |
|---|---|
| Abbott Laboratories | 66 |
| Baxter Healthcare Corp | 39 |
| Y | 26 |
| Travenol Laboratories, S.A. | 23 |
| C.R. Bard, Inc. | 22 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in FRN file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Abbott Laboratories, Inc. | 67 | 2 |
| Baxter Healthcare Corporation | 51 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FRN
Get an email the morning anything changes in FRN — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.