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FDA product code · Anesthesiology · Class 2

CBI: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

CBI is FDA's product code for "Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)": a Class 2 device classified under 21 CFR 868.5740, reviewed by the Anesthesiology panel. FDA flags it as life-sustaining or life-supporting.

510(k) review time for CBI

Across 10 510(k) clearances under CBI decided from 2018-01-01 to 2026-10-06, the median was 203 days from FDA receipt to decision. Half took between 126 and 268 days, and 80% were decided within 270 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, CBI, decisions 2018-01-01 to 2026-10-06 (n = 10)
Fastest111
25th percentile126
Median203
75th percentile268
80th percentile270
90th percentile296
Slowest477

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.

CBI in the public FDA record

Records naming CBI, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years34
Device recalls10

Counts of records, not of devices or events. Adverse event reports for CBI 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 CBI

5 FDA recognized consensus standards cite CBI, among them ISO 14408 Third edition 2016-02-15; ISO 16628 Second edition 2022-06; ISO 18190 Second edition 2025-02. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 1-119 ISO 14408 Third edition 2016-02-15 — Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
  • 1-161 ISO 16628 Second edition 2022-06 — Anaesthetic and respiratory equipment - Tracheobronchial tubes
  • 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.

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