FDA product code NHJ: Device, Positive Pressure Breathing, Intermittent
NHJ is the FDA product code for device, positive pressure breathing, intermittent. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel. FDA has cleared 26 510(k) submissions under NHJ, 5 in the last five years, from 13 different applicants. The average 510(k) review took 187 days (median 172); 266 days on average over the last three years. FDA has posted 11 recalls for NHJ devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class II |
| Regulation | 21 CFR 868.5905 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for NHJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 3 | 162 |
| 2022 | 1 | 407 |
| 2024 | 1 | 300 |
| 2025 | 1 | 273 |
| 2026 | 2 | 226 |
Compare with all 510(k) review times · Search every NHJ clearance
Top NHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abmrc, LLC | 4 | 2026-08-24 |
| Hill-Rom Services Pte, Ltd. | 4 | 2020-05-26 |
| Dima Italia Srl | 3 | 2014-10-16 |
| Vortran Medical Technology 1, Inc. | 3 | 2001-02-23 |
| Lung Assist, Inc. | 2 | 2014-03-28 |
8 more applicants have NHJ clearances. See the full list in Caduvo.
Most recent NHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260604 | Abmrc, LLC | BiWaze Clear System | 2026-08-24 | 181 |
| K253001 | Hunan Ruijiong Biotech Co., Ltd. | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | 2026-06-16 | 270 |
| K242438 | Breas Medical AB | Clearo | 2025-05-16 | 273 |
| K231728 | Abmrc, LLC | BiWaze Clear System | 2024-04-08 | 300 |
| K213564 | Abmrc, LLC | BiWaze Clear System | 2022-12-21 | 407 |
Recalls for NHJ devices
11 product recalls in 6 recall events; 11 initiated in the last five years and 9 still open. Most recent: 2026-08-03.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2024 | 3 |
| 2026 | 6 |
Frequently asked questions
What is FDA product code NHJ?
NHJ is the FDA product code for device, positive pressure breathing, intermittent. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel.
What device class is NHJ?
Class II, regulation 21 CFR 868.5905. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHJ?
Across 26 cleared submissions the average was 187 days from receipt to decision (median 172).
Which companies have the most NHJ clearances?
Abmrc, LLC (4); Hill-Rom Services Pte, Ltd. (4); Dima Italia Srl (3); Vortran Medical Technology 1, Inc. (3); Lung Assist, Inc. (2).
Have NHJ devices been recalled?
Yes: 11 product recalls across 6 recall events; the most recent began 2026-08-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NHJ
- Run a recall and safety report across every NHJ manufacturer
- Watch product code NHJ 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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