FDA product code FQL: Stocking, Medical Support (For General Medical Purposes)
FQL is the FDA product code for stocking, medical support (for general medical purposes). It is a Class I device, regulated under 21 CFR 880.5780 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under FQL, from 5 different applicants. The average 510(k) review took 49 days (median 39). FDA has posted 2 recalls for FQL devices.
Classification
| Field | Value |
|---|---|
| Device name | Stocking, Medical Support (For General Medical Purposes) |
| Device class | Class I |
| Regulation | 21 CFR 880.5780 |
| 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 FQL clearance
Top FQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Selomas, Inc. | 2 | 1982-06-23 |
| Silipos, Inc. | 1 | 1994-12-27 |
| Orthopaedic Resources Corp. | 1 | 1983-01-07 |
| Podiatry Products Corp. | 1 | 1982-12-03 |
| Jung Products, Inc. | 1 | 1982-03-18 |
Most recent FQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944240 | Silipos, Inc. | SOFT SOCK | 1994-12-27 | 117 |
| K823789 | Orthopaedic Resources Corp. | ELASTIC COMPRESSION ANKLET | 1983-01-07 | 22 |
| K823350 | Podiatry Products Corp. | ELASTIC COMPRESSION ANKLET | 1982-12-03 | 24 |
| K821259 | Selomas, Inc. | VITASAN | 1982-06-23 | 54 |
| K821260 | Selomas, Inc. | VITOFIT | 1982-06-23 | 54 |
Recalls for FQL devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-10-07.
Frequently asked questions
What is FDA product code FQL?
FQL is the FDA product code for stocking, medical support (for general medical purposes). It is a Class I device, regulated under 21 CFR 880.5780 and reviewed by the General Hospital panel.
What device class is FQL?
Class I, regulation 21 CFR 880.5780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FQL?
Across 6 cleared submissions the average was 49 days from receipt to decision (median 39).
Which companies have the most FQL clearances?
Selomas, Inc. (2); Silipos, Inc. (1); Orthopaedic Resources Corp. (1); Podiatry Products Corp. (1); Jung Products, Inc. (1).
Have FQL devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2011-10-07.
Next steps
- Run an FDA pathway report with predicate devices for product code FQL
- Run a recall and safety report across every FQL manufacturer
- Watch product code FQL 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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