FDA product code FJF: Detector, Air Bubble
FJF is the FDA product code for detector, air bubble. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FJF, from 5 different applicants. The average 510(k) review took 80 days (median 71).
Classification
| Field | Value |
|---|---|
| Device name | Detector, Air Bubble |
| 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 FJF clearance
Top FJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Minntech Corp. | 1 | 1991-02-05 |
| American Orthodontics | 1 | 1989-05-10 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1978-08-31 |
| Hospal Medical Corp. | 1 | 1978-06-22 |
| Cobe Laboratories, Inc. | 1 | 1977-10-04 |
Most recent FJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904992 | Minntech Corp. | MINNILERT AIR DETECTOR | 1991-02-05 | 90 |
| K891327 | American Orthodontics | NICKLE-TITANIUM ORTHODONTIC WIRE | 1989-05-10 | 61 |
| K781330 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BLOOD LEVEL DETECTOR-MODEL 7601 | 1978-08-31 | 29 |
| K780582 | Hospal Medical Corp. | DETECTOR, BUBBLE & FOAM | 1978-06-22 | 71 |
| K770857 | Cobe Laboratories, Inc. | DIALYSIS MACHINE, CENTRY II | 1977-10-04 | 148 |
Recalls for FJF devices
openFDA lists no recalls for product code FJF.
Frequently asked questions
What is FDA product code FJF?
FJF is the FDA product code for detector, air bubble. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJF?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJF?
Across 5 cleared submissions the average was 80 days from receipt to decision (median 71).
Which companies have the most FJF clearances?
Minntech Corp. (1); American Orthodontics (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Hospal Medical Corp. (1); Cobe Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJF
- Run a recall and safety report across every FJF manufacturer
- Watch product code FJF 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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