FDA product code BZD: Ventilator, Non-Continuous (Respirator)
BZD is the FDA product code for ventilator, non-continuous (respirator). It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel. FDA has cleared 461 510(k) submissions under BZD, 34 in the last five years, from 122 different applicants. The average 510(k) review took 155 days (median 126); 185 days on average over the last three years. FDA has posted 83 recalls for BZD devices, 27 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, Non-Continuous (Respirator) |
| 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 BZD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 208 |
| 2018 | 5 | 246 |
| 2019 | 6 | 223 |
| 2020 | 6 | 211 |
| 2021 | 6 | 205 |
| 2022 | 4 | 265 |
| 2023 | 5 | 219 |
| 2024 | 10 | 156 |
| 2025 | 7 | 184 |
| 2026 | 8 | 215 |
Compare with all 510(k) review times · Search every BZD clearance
Top BZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Resmed, Ltd. | 81 | 2019-05-07 |
| Respironics, Inc. | 67 | 2023-07-28 |
| Fisher & Paykel Healthcare, Ltd. | 25 | 2023-06-29 |
| Sleepnet Corporation | 18 | 2026-01-15 |
| Resmed Corp | 14 | 2026-06-04 |
117 more applicants have BZD clearances. See the full list in Caduvo.
Most recent BZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253044 | Resvent Medical Technology Co., Ltd. | RXiBreeze PAP System (RXiBreeze 20C) | 2026-07-23 | 304 |
| K253553 | Resmed Corp | Orion | 2026-06-04 | 202 |
| K254104 | Resmed Corp | ResScan Essentials | 2026-05-27 | 159 |
| K251920 | Dcstar, Inc. | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | 2026-05-21 | 332 |
| K253166 | BMC Medical Co., Ltd. | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | 2026-04-29 | 215 |
Recalls for BZD devices
83 product recalls in 29 recall events; 27 initiated in the last five years and 27 still open. Most recent: 2026-08-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 4 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 10 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code BZD?
BZD is the FDA product code for ventilator, non-continuous (respirator). It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel.
What device class is BZD?
Class II, regulation 21 CFR 868.5905. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZD?
Across 461 cleared submissions the average was 155 days from receipt to decision (median 126).
Which companies have the most BZD clearances?
Resmed, Ltd. (81); Respironics, Inc. (67); Fisher & Paykel Healthcare, Ltd. (25); Sleepnet Corporation (18); Resmed Corp (14).
Have BZD devices been recalled?
Yes: 83 product recalls across 29 recall events; the most recent began 2026-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code BZD
- Run a recall and safety report across every BZD manufacturer
- Watch product code BZD 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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