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FDA product code · Anesthesiology · Class 2

BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

BTT is FDA's product code for "Humidifier, Respiratory Gas, (Direct Patient Interface)": a Class 2 device classified under 21 CFR 868.5450, reviewed by the Anesthesiology panel.

510(k) review time for BTT

Across 32 510(k) clearances under BTT decided from 2018-01-01 to 2026-10-06, the median was 245 days from FDA receipt to decision. Half took between 170 and 274 days, and 80% were decided within 288 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, BTT, decisions 2018-01-01 to 2026-10-06 (n = 32)
Fastest29
25th percentile170
Median245
75th percentile274
80th percentile288
90th percentile335
Slowest828
Median days by decision year, BTT (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20232587
20242197

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.

BTT in the public FDA record

Records naming BTT, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years222
Device recalls70
Establishment listings344
GUDID device identifiers1,050

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

7 FDA recognized consensus standards cite BTT, 1 of them recognized only in part, among them ISO 80601-2-74 First edition 2017-05; 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.

  • 1-138 ISO 80601-2-74 First edition 2017-05 — Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying 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
  • 1-176 ISO 18562-4 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
  • 1-177 ISO 80601-2-74 Second edition 2021-07 — Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
  • 1-189 ISO 4135 Fourth edition 2022-01 — Anaesthetic and respiratory equipment - Vocabulary
  • 1-62 ISO 5356-1 Third edition 2004-05-15 — Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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