FDA product code BZK: Spirometer, Monitoring (W/Wo Alarm)
BZK is the FDA product code for spirometer, monitoring (w/wo alarm). It is a Class II device, regulated under 21 CFR 868.1850 and reviewed by the Anesthesiology panel. FDA has cleared 62 510(k) submissions under BZK, 1 in the last five years, from 39 different applicants. The average 510(k) review took 109 days (median 88); 233 days on average over the last three years. FDA has posted 3 recalls for BZK devices.
Classification
| Field | Value |
|---|---|
| Device name | Spirometer, Monitoring (W/Wo Alarm) |
| Device class | Class II |
| Regulation | 21 CFR 868.1850 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 281 |
| 2018 | 2 | 190 |
| 2019 | 2 | 89 |
| 2026 | 1 | 233 |
Compare with all 510(k) review times · Search every BZK clearance
Top BZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respitrace Corp. | 6 | 1986-03-20 |
| Respiratory Motion, Inc. | 4 | 2018-03-16 |
| Bear Medical Systems, Inc. | 4 | 1989-03-30 |
| Ohmeda Medical | 4 | 1986-09-12 |
| Respironics Novametrix, LLC | 3 | 2011-06-02 |
34 more applicants have BZK clearances. See the full list in Caduvo.
Most recent BZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260226 | Amptron Medical, Inc. | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | 2026-09-16 | 233 |
| K192584 | Mermaid Care A/S | BEACON Caresystem Model 00002144 | 2019-12-18 | 90 |
| K192595 | Respiratory Motion | ExSpiron 2Xi | 2019-12-17 | 88 |
| K180788 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Gas Module 3 | 2018-10-24 | 212 |
| K173181 | Respiratory Motion, Inc. | ExSpiron 1Xi | 2018-03-16 | 168 |
Recalls for BZK devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code BZK?
BZK is the FDA product code for spirometer, monitoring (w/wo alarm). It is a Class II device, regulated under 21 CFR 868.1850 and reviewed by the Anesthesiology panel.
What device class is BZK?
Class II, regulation 21 CFR 868.1850. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZK?
Across 62 cleared submissions the average was 109 days from receipt to decision (median 88).
Which companies have the most BZK clearances?
Respitrace Corp. (6); Respiratory Motion, Inc. (4); Bear Medical Systems, Inc. (4); Ohmeda Medical (4); Respironics Novametrix, LLC (3).
Have BZK devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2017-12-01.
Next steps
- Run an FDA pathway report with predicate devices for product code BZK
- Run a recall and safety report across every BZK manufacturer
- Watch product code BZK 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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