FDA product code · Anesthesiology · Class 2
BZH: Meter, Peak Flow, Spirometry
BZH is FDA's product code for "Meter, Peak Flow, Spirometry": a Class 2 device classified under 21 CFR 868.1860, reviewed by the Anesthesiology panel.
510(k) review time for BZH
Across 13 510(k) clearances under BZH decided from 2018-01-01 to 2026-10-06, the median was 232 days from FDA receipt to decision. Half took between 122 and 270 days, and 80% were decided within 331 days. These are past clearances, not a forecast for a new submission.
| Fastest | 37 |
|---|---|
| 25th percentile | 122 |
| Median | 232 |
| 75th percentile | 270 |
| 80th percentile | 331 |
| 90th percentile | 441 |
| Slowest | 459 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
BZH in the public FDA record
| 510(k) clearances, all years | 81 |
|---|
Counts of records, not of devices or events. Adverse event reports for BZH are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite BZH
5 FDA recognized consensus standards cite BZH, 1 of them recognized only in part, among them ISO 23747 Second edition 2015-08; IEEE Std 11073-10421-2023; IEEE Std 11073-10429-2022. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-178 ISO 23747 Second edition 2015-08 — Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
- 13-151 IEEE Std 11073-10421-2023 — Health Informatics-Device Interoperability - Part 10421: Personal Health Device Communication - Device Specialization - Peak expiratory flow monitor (peak flow)
- 13-154 IEEE Std 11073-10429-2022 — Health informatics - Device Interoperability - Part 10429: Personal Health Device Communication - Device Specialization - Spirometry
- 13-55 IEEE Std 11073-10421-2010 — Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
- 13-92 ISO IEEE 11073-10421 First edition 2012-11-01 (partial recognition) — Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.