FDA product code · Anesthesiology · Class 2
BTR: Tube, Tracheal (W/Wo Connector)
BTR is FDA's product code for "Tube, Tracheal (W/Wo Connector)": a Class 2 device classified under 21 CFR 868.5730, reviewed by the Anesthesiology panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for BTR
Across 26 510(k) clearances under BTR decided from 2018-01-01 to 2026-10-06, the median was 248 days from FDA receipt to decision. Half took between 196 and 288 days, and 80% were decided within 300 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 196 |
| Median | 248 |
| 75th percentile | 288 |
| 80th percentile | 300 |
| 90th percentile | 393 |
| Slowest | 448 |
| Year | Median days | n |
|---|---|---|
| 2018 | 242 | 5 |
| 2019 | 211 | 5 |
| 2025 | 258 | 7 |
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.
BTR in the public FDA record
| 510(k) clearances, all years | 242 |
|---|---|
| Device recalls | 226 |
| Establishment listings | 361 |
| GUDID device identifiers | 4,485 |
Counts of records, not of devices or events. Adverse event reports for BTR 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 BTR
12 FDA recognized consensus standards cite BTR, 1 of them recognized only in part, among them ISO 5366 First edition 2016-10-01; ISO 5361 Third edition 2016-09-01; ISO 14408 Third edition 2016-02-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-117 ISO 5366 First edition 2016-10-01 — Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
- 1-118 ISO 5361 Third edition 2016-09-01 — Anaesthetic and respiratory equipment - Tracheal tubes and connectors
- 1-119 ISO 14408 Third edition 2016-02-15 — Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
- 1-120 ISO 18190 First edition 2016-11-01 — Anaesthetic and respiratory equipment - General requirements for airways and related equipment
- 1-164 ISO 5361 Fourth edition 2023-01 — Anaesthetic and respiratory equipment - Tracheal tubes and connectors
- 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
- 1-193 ISO 18190 Second edition 2025-02 — Anaesthetic and respiratory equipment - General requirements for airways and related equipment
- 1-62 ISO 5356-1 Third edition 2004-05-15 — Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- 12-323 ISO 11990 Third edition 2018-08 — Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.