FDA product code FJB: Detector, Dialysate Level
FJB is the FDA product code for detector, dialysate level. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FJB, from 3 different applicants. The average 510(k) review took 45 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Detector, Dialysate Level |
| 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 FJB clearance
Top FJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Medical Care, Medical Products Div., Inc. | 1 | 1988-09-29 |
| Cobe Laboratories, Inc. | 1 | 1988-04-21 |
| Yankee Intl. Medical Research & Mfg., Ltd. | 1 | 1988-02-19 |
Most recent FJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883490 | National Medical Care, Medical Products Div., Inc. | ACCUFLO UF CONTROL MODULE NO. 74-0100-3 | 1988-09-29 | 44 |
| K881062 | Cobe Laboratories, Inc. | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 | 1988-04-21 | 38 |
| K875312 | Yankee Intl. Medical Research & Mfg., Ltd. | UFR DIGITAL RETROFIT | 1988-02-19 | 52 |
Recalls for FJB devices
openFDA lists no recalls for product code FJB.
Frequently asked questions
What is FDA product code FJB?
FJB is the FDA product code for detector, dialysate level. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJB?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJB?
Across 3 cleared submissions the average was 45 days from receipt to decision (median 44).
Which companies have the most FJB clearances?
National Medical Care, Medical Products Div., Inc. (1); Cobe Laboratories, Inc. (1); Yankee Intl. Medical Research & Mfg., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJB
- Run a recall and safety report across every FJB manufacturer
- Watch product code FJB 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times