FDA product code BZL: Computer, Oxygen-Uptake
BZL is the FDA product code for computer, oxygen-uptake. It is a Class II device, regulated under 21 CFR 868.1730 and reviewed by the Anesthesiology panel. FDA has cleared 33 510(k) submissions under BZL, from 26 different applicants. The average 510(k) review took 180 days (median 107).
Classification
| Field | Value |
|---|---|
| Device name | Computer, Oxygen-Uptake |
| Device class | Class II |
| Regulation | 21 CFR 868.1730 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 402 |
Compare with all 510(k) review times · Search every BZL clearance
Top BZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Graphics Corp. | 4 | 2007-04-16 |
| Healthetech, Inc. | 2 | 2002-06-14 |
| Datex Division Instrumentarium Corp. | 2 | 1993-11-24 |
| Icor AB | 2 | 1990-01-04 |
| Beckman Instruments, Inc. | 2 | 1982-10-13 |
21 more applicants have BZL clearances. See the full list in Caduvo.
Most recent BZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200076 | Tf Health Co. | Breezing Med | 2020-09-25 | 255 |
| K190561 | Cosmed Nordic Aps | NICU V'02 | 2020-09-04 | 549 |
| K110810 | Invoy Technologies, LLC | ANASCIENT BREATH MONITOR | 2011-06-21 | 90 |
| K093080 | Treymed, Inc. | METAPHOR METABOLIC MONITOR | 2010-01-22 | 114 |
| K071533 | Cosmed Srl | FITMATE SERIES | 2007-09-28 | 115 |
Recalls for BZL devices
openFDA lists no recalls for product code BZL.
Frequently asked questions
What is FDA product code BZL?
BZL is the FDA product code for computer, oxygen-uptake. It is a Class II device, regulated under 21 CFR 868.1730 and reviewed by the Anesthesiology panel.
What device class is BZL?
Class II, regulation 21 CFR 868.1730. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZL?
Across 33 cleared submissions the average was 180 days from receipt to decision (median 107).
Which companies have the most BZL clearances?
Medical Graphics Corp. (4); Healthetech, Inc. (2); Datex Division Instrumentarium Corp. (2); Icor AB (2); Beckman Instruments, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code BZL
- Run a recall and safety report across every BZL manufacturer
- Watch product code BZL 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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