FDA product code BWP: Shoe And Shoe Cover, Conductive
BWP is the FDA product code for shoe and shoe cover, conductive. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under BWP, from 3 different applicants. The average 510(k) review took 74 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Shoe And Shoe Cover, Conductive |
| Device class | Class I |
| Regulation | 21 CFR 878.4040 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BWP clearance
Top BWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kimberly-Clark Corp. | 1 | 1988-06-23 |
| Sudreca Surgical Dressings, Inc. | 1 | 1983-07-12 |
| Anago, Inc. | 1 | 1981-09-11 |
Most recent BWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880384 | Kimberly-Clark Corp. | KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT | 1988-06-23 | 147 |
| K831952 | Sudreca Surgical Dressings, Inc. | SURGICAL APPAREL SHOE COVERS | 1983-07-12 | 27 |
| K812105 | Anago, Inc. | ANOGO DISPOSABLE SHOE COVER | 1981-09-11 | 49 |
Recalls for BWP devices
openFDA lists no recalls for product code BWP.
Frequently asked questions
What is FDA product code BWP?
BWP is the FDA product code for shoe and shoe cover, conductive. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General and Plastic Surgery panel.
What device class is BWP?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BWP?
Across 3 cleared submissions the average was 74 days from receipt to decision (median 49).
Which companies have the most BWP clearances?
Kimberly-Clark Corp. (1); Sudreca Surgical Dressings, Inc. (1); Anago, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BWP
- Run a recall and safety report across every BWP manufacturer
- Watch product code BWP 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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