FDA product code · Anesthesiology · Class 2
BWF: Spirometer, Therapeutic (Incentive)
BWF is FDA's product code for "Spirometer, Therapeutic (Incentive)": a Class 2 device classified under 21 CFR 868.5690, reviewed by the Anesthesiology panel.
510(k) review time for BWF
Across 11 510(k) clearances under BWF decided from 2018-01-01 to 2026-10-06, the median was 265 days from FDA receipt to decision. Half took between 223 and 390 days, and 80% were decided within 450 days. These are past clearances, not a forecast for a new submission.
| Fastest | 59 |
|---|---|
| 25th percentile | 223 |
| Median | 265 |
| 75th percentile | 390 |
| 80th percentile | 450 |
| 90th percentile | 482 |
| Slowest | 486 |
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.
BWF in the public FDA record
| 510(k) clearances, all years | 108 |
|---|---|
| Establishment listings | 91 |
Counts of records, not of devices or events. Adverse event reports for BWF 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 BWF
4 FDA recognized consensus standards cite BWF, 1 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.