FDA product code FIR: Pump, Blood, Extra-Luminal
FIR is the FDA product code for pump, blood, extra-luminal. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under FIR, from 7 different applicants. The average 510(k) review took 41 days (median 34). FDA has posted 3 recalls for FIR devices.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Blood, Extra-Luminal |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FIR clearance
Top FIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apheresis Technologies, Inc. | 1 | 1996-06-14 |
| Cryosan, Inc. | 1 | 1983-07-19 |
| Parker Hannifin Corp. | 1 | 1983-04-12 |
| Extracorporeal Medical Specialities, Inc. | 1 | 1982-05-10 |
| 3M Health Care, Sarns | 1 | 1978-05-03 |
2 more applicants have FIR clearances. See the full list in Caduvo.
Most recent FIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961137 | Apheresis Technologies, Inc. | ATI PLASMA PUMP (PP-04) | 1996-06-14 | 85 |
| K831953 | Cryosan, Inc. | INFUSION PUMP | 1983-07-19 | 34 |
| K830818 | Parker Hannifin Corp. | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | 1983-04-12 | 28 |
| K821139 | Extracorporeal Medical Specialities, Inc. | SPS-SINGLE PATIENT SYSTEM | 1982-05-10 | 19 |
| K780410 | 3M Health Care, Sarns | BLOOD PUMP-MODE S10K | 1978-05-03 | 51 |
Recalls for FIR devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-07-09.
Frequently asked questions
What is FDA product code FIR?
FIR is the FDA product code for pump, blood, extra-luminal. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIR?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIR?
Across 7 cleared submissions the average was 41 days from receipt to decision (median 34).
Which companies have the most FIR clearances?
Apheresis Technologies, Inc. (1); Cryosan, Inc. (1); Parker Hannifin Corp. (1); Extracorporeal Medical Specialities, Inc. (1); 3M Health Care, Sarns (1).
Have FIR devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2012-07-09.
Next steps
- Run an FDA pathway report with predicate devices for product code FIR
- Run a recall and safety report across every FIR manufacturer
- Watch product code FIR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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