FDA product code · Anesthesiology · Class 2
BZG: Spirometer, Diagnostic
BZG is FDA's product code for "Spirometer, Diagnostic": a Class 2 device classified under 21 CFR 868.1840, reviewed by the Anesthesiology panel.
510(k) review time for BZG
Across 20 510(k) clearances under BZG decided from 2018-01-01 to 2026-10-06, the median was 231 days from FDA receipt to decision. Half took between 143 and 311 days, and 80% were decided within 364 days. These are past clearances, not a forecast for a new submission.
| Fastest | 70 |
|---|---|
| 25th percentile | 143 |
| Median | 231 |
| 75th percentile | 311 |
| 80th percentile | 364 |
| 90th percentile | 376 |
| Slowest | 559 |
| Year | Median days | n |
|---|---|---|
| 2020 | 126 | 5 |
| 2023 | 362 | 5 |
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.
BZG in the public FDA record
| 510(k) clearances, all years | 228 |
|---|---|
| Establishment listings | 185 |
| GUDID device identifiers | 1,170 |
Counts of records, not of devices or events. Adverse event reports for BZG 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 BZG
6 FDA recognized consensus standards cite BZG, 2 of them recognized only in part, among them ISO 18562-1 Second edition 2024-03; ISO 18562-2 Second edition 2024-03; ISO 18562-3 Second Edition 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-173 ISO 18562-1 Second edition 2024-03 (partial recognition) — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- 1-174 ISO 18562-2 Second edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- 1-175 ISO 18562-3 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- 1-176 ISO 18562-4 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
- 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
- 1-179 ISO 26782 First edition 2009-07 (partial recognition) — Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.