FDA product code BZQ: Monitor, Breathing Frequency
BZQ is the FDA product code for monitor, breathing frequency. It is a Class II device, regulated under 21 CFR 868.2375 and reviewed by the Anesthesiology panel. FDA has cleared 176 510(k) submissions under BZQ, 14 in the last five years, from 110 different applicants. The average 510(k) review took 157 days (median 122); 267 days on average over the last three years. FDA has posted 3 recalls for BZQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Breathing Frequency |
| Device class | Class II |
| Regulation | 21 CFR 868.2375 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 188 |
| 2019 | 1 | 268 |
| 2020 | 2 | 218 |
| 2021 | 2 | 214 |
| 2022 | 3 | 165 |
| 2023 | 1 | 90 |
| 2024 | 1 | 224 |
| 2025 | 7 | 238 |
| 2026 | 2 | 338 |
Compare with all 510(k) review times · Search every BZQ clearance
Top BZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aequitron Medical, Inc. | 9 | 1997-04-18 |
| Earlysense, Ltd. | 8 | 2018-01-04 |
| Healthdyne, Inc. | 8 | 1990-08-17 |
| Ge Medical Systems Information Technologies | 6 | 1997-03-06 |
| Edentec Corp. | 6 | 1996-02-06 |
105 more applicants have BZQ clearances. See the full list in Caduvo.
Most recent BZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253274 | Intelligent Dots, LLC | BedDot (G1) | 2026-06-25 | 269 |
| K251326 | Edwards Lifesciences, LLC | Respiration Rate algorithm | 2026-06-11 | 408 |
| K250093 | Linshom Medical, Inc. | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | 2025-09-26 | 255 |
| K250934 | Respiree Pte, Ltd. | Respiree Cardio- Respiratory Monitor System | 2025-08-05 | 130 |
| K243183 | Rtm Vital Signs, LLC | RTMsense Respiratory Monitoring System | 2025-06-27 | 270 |
Recalls for BZQ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-21.
Frequently asked questions
What is FDA product code BZQ?
BZQ is the FDA product code for monitor, breathing frequency. It is a Class II device, regulated under 21 CFR 868.2375 and reviewed by the Anesthesiology panel.
What device class is BZQ?
Class II, regulation 21 CFR 868.2375. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZQ?
Across 176 cleared submissions the average was 157 days from receipt to decision (median 122).
Which companies have the most BZQ clearances?
Aequitron Medical, Inc. (9); Earlysense, Ltd. (8); Healthdyne, Inc. (8); Ge Medical Systems Information Technologies (6); Edentec Corp. (6).
Have BZQ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2010-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code BZQ
- Run a recall and safety report across every BZQ manufacturer
- Watch product code BZQ 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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