FDA product code · Anesthesiology · Class 2
CAW: Generator, Oxygen, Portable
CAW is FDA's product code for "Generator, Oxygen, Portable": a Class 2 device classified under 21 CFR 868.5440, reviewed by the Anesthesiology panel.
510(k) review time for CAW
Across 44 510(k) clearances under CAW decided from 2018-01-01 to 2026-10-06, the median was 224 days from FDA receipt to decision. Half took between 160 and 291 days, and 80% were decided within 303 days. These are past clearances, not a forecast for a new submission.
| Fastest | 104 |
|---|---|
| 25th percentile | 160 |
| Median | 224 |
| 75th percentile | 291 |
| 80th percentile | 303 |
| 90th percentile | 419 |
| Slowest | 782 |
| Year | Median days | n |
|---|---|---|
| 2020 | 224 | 5 |
| 2023 | 261 | 8 |
| 2025 | 178 | 12 |
| 2026 (to 10-06, partial) | 260 | 6 |
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.
CAW in the public FDA record
| 510(k) clearances, all years | 288 |
|---|---|
| Device recalls | 44 |
| Establishment listings | 187 |
| GUDID device identifiers | 642 |
Counts of records, not of devices or events. Adverse event reports for CAW 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 CAW
5 FDA recognized consensus standards cite CAW, 1 of them recognized only in part, among them ISO 80601-2-69 Second edition 2020-11; ISO 18562-1 Second edition 2024-03; ISO 18562-2 Second edition 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-148 ISO 80601-2-69 Second edition 2020-11 — Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
- 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.