FDA product code FPX: Strip, Adhesive, Closure, Skin
FPX is the FDA product code for strip, adhesive, closure, skin. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General and Plastic Surgery panel. FDA has cleared 35 510(k) submissions under FPX, from 22 different applicants. The average 510(k) review took 71 days (median 54). FDA has posted 1 recall for FPX devices.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Adhesive, Closure, Skin |
| Device class | Class I |
| Regulation | 21 CFR 880.5240 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FPX clearance
Top FPX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Johnson & Johnson Professionals, Inc. | 7 | 1979-01-17 |
| Beiersdorf, Inc. | 6 | 1983-11-25 |
| Shur Medical Corp. | 2 | 1982-06-23 |
| American Medical Disposable, Inc. | 2 | 1980-11-12 |
| Medi-Flex Hospital Products, Inc. | 1 | 1997-05-09 |
17 more applicants have FPX clearances. See the full list in Caduvo.
Most recent FPX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970441 | Medi-Flex Hospital Products, Inc. | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | 1997-05-09 | 93 |
| K952947 | Bitco Intl. | DELPORE SKIN CLOSURE | 1995-07-24 | 28 |
| K952702 | Ttl Medical | DERMA SEAL | 1995-06-28 | 15 |
| K946321 | Cornelia Damsky, Inc. | BIOSTRIP STERILE WOUND CLOSURE STRIP | 1995-01-12 | 15 |
| K931005 | Dukal Corp. | DUKAL SKIN CLOSURE STRIP | 1993-07-14 | 138 |
Recalls for FPX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-07-18.
Frequently asked questions
What is FDA product code FPX?
FPX is the FDA product code for strip, adhesive, closure, skin. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General and Plastic Surgery panel.
What device class is FPX?
Class I, regulation 21 CFR 880.5240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FPX?
Across 35 cleared submissions the average was 71 days from receipt to decision (median 54).
Which companies have the most FPX clearances?
Johnson & Johnson Professionals, Inc. (7); Beiersdorf, Inc. (6); Shur Medical Corp. (2); American Medical Disposable, Inc. (2); Medi-Flex Hospital Products, Inc. (1).
Have FPX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code FPX
- Run a recall and safety report across every FPX manufacturer
- Watch product code FPX 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times