FDA product code FNK: Bed, Hydraulic, Adjustable Hospital
FNK is the FDA product code for bed, hydraulic, adjustable hospital. It is a Class I device, regulated under 21 CFR 880.5110 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under FNK. The average 510(k) review took 47 days (median 47). FDA has posted 4 recalls for FNK devices.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Hydraulic, Adjustable Hospital |
| Device class | Class I |
| Regulation | 21 CFR 880.5110 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FNK clearance
Top FNK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merivaara Instrumentarium Corp. | 1 | 1994-11-22 |
Most recent FNK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944929 | Merivaara Instrumentarium Corp. | OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905) | 1994-11-22 | 47 |
Recalls for FNK devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-18.
Frequently asked questions
What is FDA product code FNK?
FNK is the FDA product code for bed, hydraulic, adjustable hospital. It is a Class I device, regulated under 21 CFR 880.5110 and reviewed by the General Hospital panel.
What device class is FNK?
Class I, regulation 21 CFR 880.5110. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNK?
Across 1 cleared submissions the average was 47 days from receipt to decision (median 47).
Which companies have the most FNK clearances?
Merivaara Instrumentarium Corp. (1).
Have FNK devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2014-04-18.
Next steps
- Run an FDA pathway report with predicate devices for product code FNK
- Run a recall and safety report across every FNK manufacturer
- Watch product code FNK 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 General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times