FDA product code FNJ: Bed, Manual
FNJ is the FDA product code for bed, manual. It is a Class I device, regulated under 21 CFR 880.5120 and reviewed by the General Hospital panel. FDA has cleared 39 510(k) submissions under FNJ, from 32 different applicants. The average 510(k) review took 56 days (median 37). FDA has posted 7 recalls for FNJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Manual |
| Device class | Class I |
| Regulation | 21 CFR 880.5120 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FNJ clearance
Top FNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brenner Metal Prod Corp. | 4 | 1987-01-20 |
| Med Service, Inc. | 3 | 1988-11-01 |
| Med Fusion Systems, Inc. | 3 | 1978-01-26 |
| Noritage, Inc. | 1 | 1994-01-26 |
| Warsaw Orthopedic, Inc. | 1 | 1989-06-15 |
27 more applicants have FNJ clearances. See the full list in Caduvo.
Most recent FNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934298 | Noritage, Inc. | KING KRIB | 1994-01-26 | 146 |
| K892877 | Warsaw Orthopedic, Inc. | CRADLE, HOSPITAL BED CLOTHING | 1989-06-15 | 57 |
| K885241 | King Mfg. Co. | BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT | 1989-02-24 | 65 |
| K884542 | Commercial Products & Engineering Co. | SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED | 1988-11-21 | 21 |
| K881725 | Envirotents, Inc. | ENVIROTENT (BED) | 1988-11-08 | 200 |
Recalls for FNJ devices
7 product recalls in 4 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-04-21.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code FNJ?
FNJ is the FDA product code for bed, manual. It is a Class I device, regulated under 21 CFR 880.5120 and reviewed by the General Hospital panel.
What device class is FNJ?
Class I, regulation 21 CFR 880.5120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNJ?
Across 39 cleared submissions the average was 56 days from receipt to decision (median 37).
Which companies have the most FNJ clearances?
Brenner Metal Prod Corp. (4); Med Service, Inc. (3); Med Fusion Systems, Inc. (3); Noritage, Inc. (1); Warsaw Orthopedic, Inc. (1).
Have FNJ devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2022-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FNJ
- Run a recall and safety report across every FNJ manufacturer
- Watch product code FNJ 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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