FDA product code FRL: Fiber, Medical, Absorbent
FRL is the FDA product code for fiber, medical, absorbent. It is a Class I device, regulated under 21 CFR 880.5300 and reviewed by the General Hospital panel. FDA has cleared 19 510(k) submissions under FRL, from 15 different applicants. The average 510(k) review took 82 days (median 39). FDA has posted 6 recalls for FRL devices.
Classification
| Field | Value |
|---|---|
| Device name | Fiber, Medical, Absorbent |
| Device class | Class I |
| Regulation | 21 CFR 880.5300 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top FRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Hospital Supply Corp. | 4 | 1981-04-15 |
| Medical Engineering Corp. | 2 | 1980-02-19 |
| Quick-Med Technologies, Inc. | 1 | 2013-05-24 |
| Milliken Healthcare Products, LLC | 1 | 2011-11-04 |
| Milliken Chemical | 1 | 2006-12-22 |
10 more applicants have FRL clearances. See the full list in Caduvo.
Most recent FRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121898 | Quick-Med Technologies, Inc. | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE | 2013-05-24 | 329 |
| K110715 | Milliken Healthcare Products, LLC | INTERDRY SILVER | 2011-11-04 | 234 |
| K061615 | Milliken Chemical | INTERDRY TEXTILE WITH SILVER | 2006-12-22 | 196 |
| K931626 | Carapace, Inc. | CARAPACE STERILE COTTON BALLS | 1993-12-02 | 244 |
| K914081 | Icn Pharmaceuticals, Inc. | ICAN COTTON RAYON BALLS | 1991-10-09 | 28 |
Recalls for FRL devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-05-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code FRL?
FRL is the FDA product code for fiber, medical, absorbent. It is a Class I device, regulated under 21 CFR 880.5300 and reviewed by the General Hospital panel.
What device class is FRL?
Class I, regulation 21 CFR 880.5300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FRL?
Across 19 cleared submissions the average was 82 days from receipt to decision (median 39).
Which companies have the most FRL clearances?
American Hospital Supply Corp. (4); Medical Engineering Corp. (2); Quick-Med Technologies, Inc. (1); Milliken Healthcare Products, LLC (1); Milliken Chemical (1).
Have FRL devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2021-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code FRL
- Run a recall and safety report across every FRL manufacturer
- Watch product code FRL 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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