FDA product code BZC: Calculator, Pulmonary Function Data
BZC is the FDA product code for calculator, pulmonary function data. It is a Class II device, regulated under 21 CFR 868.1880 and reviewed by the Anesthesiology panel. FDA has cleared 90 510(k) submissions under BZC, 1 in the last five years, from 60 different applicants. The average 510(k) review took 156 days (median 100); 229 days on average over the last three years. FDA has posted 5 recalls for BZC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calculator, Pulmonary Function Data |
| Device class | Class II |
| Regulation | 21 CFR 868.1880 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 285 |
| 2018 | 1 | 172 |
| 2019 | 2 | 190 |
| 2024 | 1 | 229 |
Compare with all 510(k) review times · Search every BZC clearance
Top BZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Erich Jaeger, Inc. | 5 | 1986-02-21 |
| Novametrix Medical Systems, Inc. | 4 | 1998-10-16 |
| Warren E. Collins, Inc. | 4 | 1983-08-31 |
| Cosmed Srl | 3 | 2017-06-20 |
| P.K. Morgan , Ltd. | 3 | 1997-04-01 |
55 more applicants have BZC clearances. See the full list in Caduvo.
Most recent BZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240293 | Techbopulm, Ltd. | STS | 2024-09-17 | 229 |
| K183567 | Vyaire Medical | Vyntus/SentrySuite Product Line | 2019-08-23 | 245 |
| K190853 | Vyaire Medical, Inc. | Vyntus BODY | 2019-08-16 | 136 |
| K181524 | Vyaire Medical, Inc. | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | 2018-11-30 | 172 |
| K162515 | Cosmed Srl | COSMED K5 Wearable Metabolic Technology | 2017-06-20 | 285 |
Recalls for BZC devices
5 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code BZC?
BZC is the FDA product code for calculator, pulmonary function data. It is a Class II device, regulated under 21 CFR 868.1880 and reviewed by the Anesthesiology panel.
What device class is BZC?
Class II, regulation 21 CFR 868.1880. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZC?
Across 90 cleared submissions the average was 156 days from receipt to decision (median 100).
Which companies have the most BZC clearances?
Erich Jaeger, Inc. (5); Novametrix Medical Systems, Inc. (4); Warren E. Collins, Inc. (4); Cosmed Srl (3); P.K. Morgan , Ltd. (3).
Have BZC devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code BZC
- Run a recall and safety report across every BZC manufacturer
- Watch product code BZC 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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