FDA product code EPP: Splint, Nasal
EPP is the FDA product code for splint, nasal. It is a Class I device, regulated under 21 CFR 874.5800 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 15 510(k) submissions under EPP, from 11 different applicants. The average 510(k) review took 51 days (median 43). FDA has posted 2 recalls for EPP devices.
Classification
| Field | Value |
|---|---|
| Device name | Splint, Nasal |
| Device class | Class I |
| Regulation | 21 CFR 874.5800 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EPP clearance
Top EPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exmoor Plastics , Ltd. | 4 | 1987-03-04 |
| Xomed, Inc. | 2 | 1981-03-31 |
| Wfr/Aquaplast Corp. | 1 | 1994-07-29 |
| Micromed Development Corp. | 1 | 1994-07-08 |
| Microbio-Medics, Inc. | 1 | 1989-12-08 |
6 more applicants have EPP clearances. See the full list in Caduvo.
Most recent EPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942158 | Wfr/Aquaplast Corp. | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | 1994-07-29 | 87 |
| K942724 | Micromed Development Corp. | EXTERNAL NASAL SPLINT | 1994-07-08 | 29 |
| K895502 | Microbio-Medics, Inc. | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | 1989-12-08 | 87 |
| K890599 | Hood Laboratories | HOOD NASAL SPLINT | 1989-03-17 | 39 |
| K882244 | Richards Medical Co., Inc. | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | 1988-06-23 | 23 |
Recalls for EPP devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-02-21.
Frequently asked questions
What is FDA product code EPP?
EPP is the FDA product code for splint, nasal. It is a Class I device, regulated under 21 CFR 874.5800 and reviewed by the Ear, Nose and Throat panel.
What device class is EPP?
Class I, regulation 21 CFR 874.5800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EPP?
Across 15 cleared submissions the average was 51 days from receipt to decision (median 43).
Which companies have the most EPP clearances?
Exmoor Plastics , Ltd. (4); Xomed, Inc. (2); Wfr/Aquaplast Corp. (1); Micromed Development Corp. (1); Microbio-Medics, Inc. (1).
Have EPP devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2011-02-21.
Next steps
- Run an FDA pathway report with predicate devices for product code EPP
- Run a recall and safety report across every EPP manufacturer
- Watch product code EPP 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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