FDA product code KHJ: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
KHJ is the FDA product code for polymer, ent synthetic-polyamide (mesh or foil material). It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 34 510(k) submissions under KHJ, 2 in the last five years, from 19 different applicants. The average 510(k) review took 131 days (median 92); 235 days on average over the last three years. FDA has posted 2 recalls for KHJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KHJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 268 |
| 2026 | 1 | 202 |
Compare with all 510(k) review times · Search every KHJ clearance
Top KHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ceremed , Inc. | 8 | 2013-09-12 |
| Xomed, Inc. | 5 | 2000-06-03 |
| Cook Biotech Incorporated | 2 | 2024-05-24 |
| Cook Biotech Incorprated | 2 | 2015-09-16 |
| Curamedical, BV | 2 | 2006-04-13 |
14 more applicants have KHJ clearances. See the full list in Caduvo.
Most recent KHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260266 | Grace Medical, Inc. | Tympendi (810) | 2026-08-18 | 202 |
| K232646 | Cook Biotech Incorporated | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | 2024-05-24 | 268 |
| K161000 | Cook Biotech Incorporated | Biodesign Otologic Repair Graft | 2016-05-11 | 30 |
| K150594 | Cook Biotech Incorprated | Biodesign Otologic Repair Graft | 2015-09-16 | 191 |
| K132198 | Ceremed , Inc. | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | 2013-09-12 | 58 |
Recalls for KHJ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-11-22.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KHJ?
KHJ is the FDA product code for polymer, ent synthetic-polyamide (mesh or foil material). It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel.
What device class is KHJ?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code KHJ?
Across 34 cleared submissions the average was 131 days from receipt to decision (median 92).
Which companies have the most KHJ clearances?
Ceremed , Inc. (8); Xomed, Inc. (5); Cook Biotech Incorporated (2); Cook Biotech Incorprated (2); Curamedical, BV (2).
Have KHJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KHJ
- Run a recall and safety report across every KHJ manufacturer
- Watch product code KHJ 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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