FDA product code FPY: Sheet, Burn
FPY is the FDA product code for sheet, burn. It is a Class I device, regulated under 21 CFR 880.5180 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under FPY, from 13 different applicants. The average 510(k) review took 123 days (median 74). FDA has posted 1 recall for FPY devices.
Classification
| Field | Value |
|---|---|
| Device name | Sheet, Burn |
| Device class | Class I |
| Regulation | 21 CFR 880.5180 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FPY clearance
Top FPY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pilgrim Medical Services | 3 | 1990-07-03 |
| Levtrade Intl. (Pty) , Ltd. | 2 | 1993-04-20 |
| American Medical Disposable, Inc. | 2 | 1979-12-20 |
| Consolidated Products & Services, Inc. | 1 | 1994-01-21 |
| Gam Industries, Inc. | 1 | 1993-04-20 |
8 more applicants have FPY clearances. See the full list in Caduvo.
Most recent FPY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930759 | Consolidated Products & Services, Inc. | CP & S STERILE BURN SHEET | 1994-01-21 | 343 |
| K921471 | Levtrade Intl. (Pty) , Ltd. | BURNSHIELD TRAUMA DRESSING | 1993-04-20 | 389 |
| K921470 | Levtrade Intl. (Pty) , Ltd. | BURNSHIELD FIRE BLANKET | 1993-04-20 | 389 |
| K926290 | Gam Industries, Inc. | BURN SHEET | 1993-04-20 | 127 |
| K900442 | Pilgrim Medical Services | BURNS CASUALTY SHEET BURN ROLL | 1990-07-03 | 154 |
Recalls for FPY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code FPY?
FPY is the FDA product code for sheet, burn. It is a Class I device, regulated under 21 CFR 880.5180 and reviewed by the General and Plastic Surgery panel.
What device class is FPY?
Class I, regulation 21 CFR 880.5180. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FPY?
Across 17 cleared submissions the average was 123 days from receipt to decision (median 74).
Which companies have the most FPY clearances?
Pilgrim Medical Services (3); Levtrade Intl. (Pty) , Ltd. (2); American Medical Disposable, Inc. (2); Consolidated Products & Services, Inc. (1); Gam Industries, Inc. (1).
Have FPY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-06-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FPY
- Run a recall and safety report across every FPY manufacturer
- Watch product code FPY 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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