FDA product code FXP: Cover, Shoe, Operating-Room
FXP is the FDA product code for cover, shoe, operating-room. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 36 510(k) submissions under FXP, from 29 different applicants. The average 510(k) review took 88 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Cover, Shoe, Operating-Room |
| Device class | Class I |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FXP clearance
Top FXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| James River Corp. | 3 | 1988-09-15 |
| Abco Dealers, Inc. | 3 | 1987-08-04 |
| Amerasia Corp. | 2 | 1995-10-23 |
| Tecnol New Jersey Wound Care, Inc. | 2 | 1989-06-23 |
| Procter & Gamble Mfg. Co. | 2 | 1980-08-04 |
24 more applicants have FXP clearances. See the full list in Caduvo.
Most recent FXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971076 | Primeline Medical Products, Inc. | PRIMED SHOE COVERS, PRIMED HEAD COVERS | 1998-01-13 | 295 |
| K971191 | Far East Science & Technology Development Co., Ltd. | FAR-EAST SHOE COVERS | 1997-07-10 | 101 |
| K970815 | Allegiance Healthcare Corp. | CONVERTORS IMPERVIOUS SHOE COVERS | 1997-03-27 | 21 |
| K961342 | Copioumed Intl., Inc. | SHOE COVER, NON-STERILE | 1996-12-30 | 285 |
| K955835 | Instrument Makar, Inc. | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | 1996-11-19 | 329 |
Recalls for FXP devices
openFDA lists no recalls for product code FXP.
Frequently asked questions
What is FDA product code FXP?
FXP is the FDA product code for cover, shoe, operating-room. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FXP?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FXP?
Across 36 cleared submissions the average was 88 days from receipt to decision (median 36).
Which companies have the most FXP clearances?
James River Corp. (3); Abco Dealers, Inc. (3); Amerasia Corp. (2); Tecnol New Jersey Wound Care, Inc. (2); Procter & Gamble Mfg. Co. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FXP
- Run a recall and safety report across every FXP manufacturer
- Watch product code FXP 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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