FDA product code · Anesthesiology
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
Product code BTT covers Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II device regulated under 21 CFR 868.5450. FDA has cleared 221 devices in this code, 4 of them in the last 12 months. Median review time across the 221 most recent decisions is 98 days. openFDA lists 69 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5450
- Review panel
- Anesthesiology
- Clearances
- 221
What is happening in BTT right now?
BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0158-2026). The code is crowded, scoring 63 of 100 — 96 companies hold a clearance here and 4 arrived in the last 12 months (BTT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0158-2026 |
| Crowding | Context | BTT:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in BTT?
FDA has cleared 221 devices under product code BTT since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254078 | HVT 2.0 | Vapotherm, Inc. | |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP | |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Ltd. | |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | |
| K241778 | Hudson RCI Comfort Flo® CubCannula | Medline Industries, LP | |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. |
How long does FDA review take for BTT?
The median FDA review time for BTT is 98 days, measured across the 221 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in BTT?
openFDA lists 69 recall records against product code BTT. A recall record covers one firm's corrective action and may span many device lots.
Z-0158-2026Open, ClassifiedFisher & Paykel Healthcare, Ltd.
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Z-1823-2024Open, ClassifiedFisher & Paykel Healthcare, Ltd.
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Z-1272-2023Open, ClassifiedVapotherm, Inc.
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.
Z-1385-2022CompletedHamilton Medical AG
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
Z-1112-2020TerminatedTeleflex Medical
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Showing the 5 most recently initiated of 69. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for BTT?
MAUDE holds 3,805 adverse-event reports naming product code BTT, 2,351 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in BTT unusual?
4 months sit above BTT's own expected range: 1 February 2025, 1 April 2025, 1 October 2025, 1 November 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 38 | Insufficient history | No expected range — too little history | |
| 63 | Insufficient history | No expected range — too little history | |
| 86 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 68 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 62 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 42 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 49 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 51 | Insufficient history | No expected range — too little history | |
| 42 | 29–51 | Within expected (29–51) | |
| 48 | 27–44 | Above expected (27–44) | |
| 45 | 32–56 | Within expected (32–56) | |
| 69 | 33–59 | Above expected (33–59) | |
| 65 | 31–68 | Within expected (31–68) | |
| 63 | 33–80 | Within expected (33–80) | |
| 65 | 52–132 | Within expected (52–132) | |
| 68 | 33–93 | Within expected (33–93) | |
| 85 | 38–98 | Within expected (38–98) | |
| 223 | 43–102 | Above expected (43–102) | |
| 481 | 21–192 | Above expected (21–192) | |
| 483 | 0–519 | Within expected (0–519) | |
| 389 | 0–758 | Within expected (0–758) | |
| 290 | 0–656 | Within expected (0–656) | |
| 351 | 0–709 | Within expected (0–709) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in BTT.
What are the predicate devices in BTT?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in BTT?
Across the 221 most recent decisions, these applicants filed most often in BTT.
| Applicant | Recent clearances |
|---|---|
| Fisher & Paykel Healthcare, Ltd. | 25 |
| Fisher & Paykel Allied Products , Ltd. | 11 |
| Vapotherm, Inc. | 10 |
| Travenol Laboratories, S.A. | 9 |
| Respiratory Care, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in BTT files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | 28 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch BTT
Get an email the morning anything changes in BTT — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.