FDA product code BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)
BTT is the FDA product code for humidifier, respiratory gas, (direct patient interface). It is a Class II device, regulated under 21 CFR 868.5450 and reviewed by the Anesthesiology panel. FDA has cleared 222 510(k) submissions under BTT, 25 in the last five years, from 100 different applicants. The average 510(k) review took 151 days (median 98); 180 days on average over the last three years. FDA has posted 70 recalls for BTT devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class II |
| Regulation | 21 CFR 868.5450 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for BTT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 307 |
| 2018 | 2 | 533 |
| 2019 | 1 | 177 |
| 2020 | 2 | 298 |
| 2021 | 2 | 274 |
| 2022 | 3 | 242 |
| 2023 | 7 | 267 |
| 2024 | 7 | 276 |
| 2025 | 4 | 96 |
| 2026 | 4 | 168 |
Compare with all 510(k) review times · Search every BTT clearance
Top BTT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | 25 | 2025-12-19 |
| Fisher & Paykel Allied Products , Ltd. | 11 | 1988-07-08 |
| Vapotherm, Inc. | 10 | 2026-04-13 |
| Travenol Laboratories, S.A. | 9 | 1985-06-20 |
| Respiratory Care, Inc. | 8 | 1988-11-21 |
95 more applicants have BTT clearances. See the full list in Caduvo.
Most recent BTT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262268 | Fisher and Paykel Healthcare Limited | Optiflow Oxygen Kit (AA484J) | 2026-08-27 | 52 |
| K254078 | Vapotherm, Inc. | HVT 2.0 | 2026-04-13 | 116 |
| K251448 | Flexicare Medical Limited. | FL-10000U Respiratory Humidifier | 2026-01-16 | 252 |
| K251419 | Laboratorios Biogalenic S.A. DE C.V. | Laboratorios Biogalenic Sterile Water for Inhalation, USP | 2026-01-14 | 252 |
| K253479 | Fisher & Paykel Healthcare, Ltd. | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | 2025-12-19 | 66 |
Recalls for BTT devices
70 product recalls in 25 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0379 — Direct admission of patient for hospital observation care
Frequently asked questions
What is FDA product code BTT?
BTT is the FDA product code for humidifier, respiratory gas, (direct patient interface). It is a Class II device, regulated under 21 CFR 868.5450 and reviewed by the Anesthesiology panel.
What device class is BTT?
Class II, regulation 21 CFR 868.5450. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTT?
Across 222 cleared submissions the average was 151 days from receipt to decision (median 98).
Which companies have the most BTT clearances?
Fisher & Paykel Healthcare, Ltd. (25); Fisher & Paykel Allied Products , Ltd. (11); Vapotherm, Inc. (10); Travenol Laboratories, S.A. (9); Respiratory Care, Inc. (8).
Have BTT devices been recalled?
Yes: 70 product recalls across 25 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code BTT
- Run a recall and safety report across every BTT manufacturer
- Watch product code BTT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times