FDA product code HAE: Rongeur, Manual
HAE is the FDA product code for rongeur, manual. It is a Class II device, regulated under 21 CFR 882.4840 and reviewed by the Neurology panel. FDA has cleared 37 510(k) submissions under HAE, 6 in the last five years, from 28 different applicants. The average 510(k) review took 158 days (median 149); 242 days on average over the last three years. FDA has posted 2 recalls for HAE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Rongeur, Manual |
| Device class | Class II |
| Regulation | 21 CFR 882.4840 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HAE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 211 |
| 2020 | 2 | 154 |
| 2021 | 1 | 405 |
| 2022 | 2 | 277 |
| 2023 | 2 | 120 |
| 2025 | 1 | 267 |
| 2026 | 1 | 216 |
Compare with all 510(k) review times · Search every HAE clearance
Top HAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxano, Inc. | 6 | 2012-07-27 |
| Morpheus AG | 3 | 2023-03-03 |
| Integra Lifesciences Corp. | 2 | 2015-04-16 |
| Von Zeppelin GmbH | 2 | 1990-12-11 |
| Tontarra Medizintechnik GmbH | 1 | 2026-09-15 |
23 more applicants have HAE clearances. See the full list in Caduvo.
Most recent HAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260446 | Tontarra Medizintechnik GmbH | Tontarra Punches and Rongeurs | 2026-09-15 | 216 |
| K242759 | Geister Medizin Technik GmbH | Geister K-Rex rongeurs | 2025-06-06 | 267 |
| K223596 | Aesculap, Inc. | SQ.line KERRISON | 2023-06-29 | 209 |
| K230256 | Morpheus AG | Rebellion, Phantom Multi-Bite Kerrison Rongeur | 2023-03-03 | 31 |
| K221818 | Morpheus AG | Rebellion; Phantom Multi-Bite Kerrison Rongeur | 2022-10-07 | 106 |
Recalls for HAE devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-30.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code HAE?
HAE is the FDA product code for rongeur, manual. It is a Class II device, regulated under 21 CFR 882.4840 and reviewed by the Neurology panel.
What device class is HAE?
Class II, regulation 21 CFR 882.4840. Typical premarket route: 510(k).
How long does a 510(k) take for product code HAE?
Across 37 cleared submissions the average was 158 days from receipt to decision (median 149).
Which companies have the most HAE clearances?
Baxano, Inc. (6); Morpheus AG (3); Integra Lifesciences Corp. (2); Von Zeppelin GmbH (2); Tontarra Medizintechnik GmbH (1).
Have HAE devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-10-30.
Next steps
- Run an FDA pathway report with predicate devices for product code HAE
- Run a recall and safety report across every HAE manufacturer
- Watch product code HAE 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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