FDA product code FIB: Protector, Transducer, Dialysis
FIB is the FDA product code for protector, transducer, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 35 510(k) submissions under FIB, 1 in the last five years, from 26 different applicants. The average 510(k) review took 102 days (median 78); 158 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Protector, Transducer, Dialysis |
| 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 |
510(k) clearances per year for FIB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 158 |
Compare with all 510(k) review times · Search every FIB clearance
Top FIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Filtertek, Inc. | 5 | 1991-08-30 |
| Medisystems Corp. | 3 | 1998-11-25 |
| Nipro Medical Corp. | 2 | 2001-04-27 |
| Fresenius Medical Care North America | 2 | 2000-12-01 |
| Mediflex Intl. | 2 | 1990-05-15 |
21 more applicants have FIB clearances. See the full list in Caduvo.
Most recent FIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240164 | Bain Medical Equipment (Guangzhou) Co., Ltd. | NovaLine SP-C35 Transducer Protector (956007) | 2024-06-28 | 158 |
| K072988 | Nipro Medical Corporation | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | 2008-02-21 | 121 |
| K001971 | Ofi Biomedica S.P.A. | HEMODIALYSIS TUBING SETS | 2001-05-24 | 330 |
| K010264 | Nipro Medical Corp. | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | 2001-04-27 | 88 |
| K001465 | Nipro Medical Corp. | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | 2000-12-05 | 209 |
Recalls for FIB devices
openFDA lists no recalls for product code FIB.
Frequently asked questions
What is FDA product code FIB?
FIB is the FDA product code for protector, transducer, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIB?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIB?
Across 35 cleared submissions the average was 102 days from receipt to decision (median 78).
Which companies have the most FIB clearances?
Filtertek, Inc. (5); Medisystems Corp. (3); Nipro Medical Corp. (2); Fresenius Medical Care North America (2); Mediflex Intl. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FIB
- Run a recall and safety report across every FIB manufacturer
- Watch product code FIB 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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