FDA product code FQM: Bandage, Elastic
FQM is the FDA product code for bandage, elastic. It is a Class I device, regulated under 21 CFR 880.5075 and reviewed by the General Hospital panel. FDA has cleared 42 510(k) submissions under FQM, from 28 different applicants. The average 510(k) review took 39 days (median 27). FDA has posted 30 recalls for FQM devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bandage, Elastic |
| Device class | Class I |
| Regulation | 21 CFR 880.5075 |
| 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 FQM clearance
Top FQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conco Medical Co. | 5 | 1976-07-19 |
| Stan-Pak Ent. | 3 | 1982-02-05 |
| Abco Dealers, Inc. | 3 | 1980-12-30 |
| Secol Co. | 3 | 1980-12-11 |
| Pollak (Intl.), Ltd. | 2 | 1980-09-09 |
23 more applicants have FQM clearances. See the full list in Caduvo.
Most recent FQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040936 | Leda Co., Ltd. | PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE | 2004-05-03 | 24 |
| K040054 | Theodore Barash | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE | 2004-04-27 | 106 |
| K013244 | Med Gen, Inc. | COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE | 2001-12-07 | 70 |
| K952738 | Skin Saver Systems, Inc. | SKIN SAVER SYSTEMS | 1995-09-29 | 107 |
| K872868 | Aspen Laboratories, Inc. | ASPEN ESMARK BANDAGE | 1987-07-31 | 10 |
Recalls for FQM devices
30 product recalls in 19 recall events; 7 initiated in the last five years and 6 still open. Most recent: 2026-02-27.
| Year | Recalls |
|---|---|
| 2017 | 7 |
| 2018 | 1 |
| 2019 | 6 |
| 2020 | 1 |
| 2022 | 3 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FQM?
FQM is the FDA product code for bandage, elastic. It is a Class I device, regulated under 21 CFR 880.5075 and reviewed by the General Hospital panel.
What device class is FQM?
Class I, regulation 21 CFR 880.5075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FQM?
Across 42 cleared submissions the average was 39 days from receipt to decision (median 27).
Which companies have the most FQM clearances?
Conco Medical Co. (5); Stan-Pak Ent. (3); Abco Dealers, Inc. (3); Secol Co. (3); Pollak (Intl.), Ltd. (2).
Have FQM devices been recalled?
Yes: 30 product recalls across 19 recall events; the most recent began 2026-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code FQM
- Run a recall and safety report across every FQM manufacturer
- Watch product code FQM 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