FDA product code KAE: Forceps, Ent
KAE is the FDA product code for forceps, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 14 510(k) submissions under KAE, from 6 different applicants. The average 510(k) review took 52 days (median 40). FDA has posted 1 recall for KAE devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| 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 KAE clearance
Top KAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 4 | 1978-01-17 |
| Artiberia | 3 | 1985-06-11 |
| Microtek Medical, Inc. | 3 | 1984-01-11 |
| Treace Medical, Inc. | 2 | 1982-09-09 |
| Downs Surgical , Ltd. | 1 | 1986-02-14 |
1 more applicants have KAE clearances. See the full list in Caduvo.
Most recent KAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853708 | Downs Surgical , Ltd. | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE | 1986-02-14 | 163 |
| K851795 | Artiberia | 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS | 1985-06-11 | 47 |
| K851794 | Artiberia | 41-180 TO 41-246 VARIOUS NASAL FORCEPS | 1985-06-11 | 47 |
| K851775 | Artiberia | 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS | 1985-06-11 | 47 |
| K833608 | Microtek Medical, Inc. | GOLD ALLIGATOR FORCEPS | 1984-01-11 | 91 |
Recalls for KAE devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-31.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code KAE?
KAE is the FDA product code for forceps, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KAE?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAE?
Across 14 cleared submissions the average was 52 days from receipt to decision (median 40).
Which companies have the most KAE clearances?
Edward Weck, Inc. (4); Artiberia (3); Microtek Medical, Inc. (3); Treace Medical, Inc. (2); Downs Surgical , Ltd. (1).
Have KAE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code KAE
- Run a recall and safety report across every KAE manufacturer
- Watch product code KAE 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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