FDA product code DWL: Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
DWL is the FDA product code for stocking, medical support (to prevent pooling of blood in legs). It is a Class II device, regulated under 21 CFR 880.5780 and reviewed by the General Hospital panel. FDA has cleared 64 510(k) submissions under DWL, from 49 different applicants. The average 510(k) review took 105 days (median 80). FDA has posted 4 recalls for DWL devices.
Classification
| Field | Value |
|---|---|
| Device name | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) |
| Device class | Class II |
| Regulation | 21 CFR 880.5780 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Top DWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jobst Institute, Inc. | 6 | 1995-12-13 |
| Medline Industries, Inc. | 2 | 2014-08-21 |
| Bsn Medical, Inc. | 2 | 2013-07-10 |
| Medi USA, LP | 2 | 2005-12-05 |
| Bsn-Jobst, Inc. | 2 | 2003-08-28 |
44 more applicants have DWL clearances. See the full list in Caduvo.
Most recent DWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141127 | Medline Industries, Inc. | MEDLINE ANTI-EMBOLISM STOCKING | 2014-08-21 | 112 |
| K131496 | Bsn Medical, Inc. | BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) | 2013-07-10 | 48 |
| K122485 | Encircle Medical Devices , Ltd. | ENCIRCLE COMPRESSION THERAPY STOCKING | 2013-04-23 | 252 |
| K123820 | Bossong Hosiery Mills, Inc. | BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS | 2013-04-02 | 111 |
| K123085 | 3M Company | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE | 2012-12-20 | 80 |
Recalls for DWL devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-19.
Frequently asked questions
What is FDA product code DWL?
DWL is the FDA product code for stocking, medical support (to prevent pooling of blood in legs). It is a Class II device, regulated under 21 CFR 880.5780 and reviewed by the General Hospital panel.
What device class is DWL?
Class II, regulation 21 CFR 880.5780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DWL?
Across 64 cleared submissions the average was 105 days from receipt to decision (median 80).
Which companies have the most DWL clearances?
Jobst Institute, Inc. (6); Medline Industries, Inc. (2); Bsn Medical, Inc. (2); Medi USA, LP (2); Bsn-Jobst, Inc. (2).
Have DWL devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2014-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code DWL
- Run a recall and safety report across every DWL manufacturer
- Watch product code DWL 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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