FDA product code FXO: Suit, Surgical
FXO is the FDA product code for suit, surgical. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under FXO, from 6 different applicants. The average 510(k) review took 58 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Suit, Surgical |
| 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 FXO clearance
Top FXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Btp Industries, Inc. | 1 | 1992-05-05 |
| Pro-Safe Professional Linens, Inc. | 1 | 1989-04-14 |
| A Plus International, Inc. | 1 | 1988-06-23 |
| Ulti-Med Intl., Inc. | 1 | 1987-01-12 |
| Kimberly-Clark Corp. | 1 | 1983-05-16 |
1 more applicants have FXO clearances. See the full list in Caduvo.
Most recent FXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914615 | Btp Industries, Inc. | BTP(TM) CENTRALINE(TM) SUIT | 1992-05-05 | 201 |
| K891212 | Pro-Safe Professional Linens, Inc. | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | 1989-04-14 | 38 |
| K882282 | A Plus International, Inc. | SUIT, SURGICAL | 1988-06-23 | 23 |
| K865022 | Ulti-Med Intl., Inc. | SURGICAL GARMENTS | 1987-01-12 | 20 |
| K831207 | Kimberly-Clark Corp. | SPUNGUARD SCRUB SUIT | 1983-05-16 | 34 |
Recalls for FXO devices
openFDA lists no recalls for product code FXO.
Frequently asked questions
What is FDA product code FXO?
FXO is the FDA product code for suit, surgical. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FXO?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FXO?
Across 6 cleared submissions the average was 58 days from receipt to decision (median 32).
Which companies have the most FXO clearances?
Btp Industries, Inc. (1); Pro-Safe Professional Linens, Inc. (1); A Plus International, Inc. (1); Ulti-Med Intl., Inc. (1); Kimberly-Clark Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FXO
- Run a recall and safety report across every FXO manufacturer
- Watch product code FXO 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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