FDA product code · Anesthesiology
BTMVentilator, Emergency, Manual (Resuscitator)
Product code BTM covers Ventilator, Emergency, Manual (Resuscitator), a Class II device regulated under 21 CFR 868.5915. FDA has cleared 209 devices in this code, 1 of them in the last 12 months. Median review time across the 209 most recent decisions is 87 days. openFDA lists 97 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5915
- Review panel
- Anesthesiology
- Clearances
- 209
What is happening in BTM right now?
BTM (Ventilator, Emergency, Manual (Resuscitator)) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-2357-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2357-2026 |
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 BTM?
FDA has cleared 209 devices under product code BTM since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical AS | |
| K243861 | butterflyBVM | Compact Medical, Inc. | |
| K221841 | EOlife® | Archeon | |
| K212905 | Sotair Device | Safe Bvm Corporation | |
| K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | Flexicare Medical Limited. | |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | Foremount Enterprise Co., Ltd. | |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | Ambu A/S | |
| K132172 | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | |
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical |
How long does FDA review take for BTM?
The median FDA review time for BTM is 87 days, measured across the 209 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 BTM?
openFDA lists 97 recall records against product code BTM. A recall record covers one firm's corrective action and may span many device lots.
Z-2357-2026Open, ClassifiedDatex-Ohmeda, Inc.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Z-2181-2025Open, ClassifiedAmbu Inc.
Potential for the manometer port being blocked rendering the manometer non-functional.
Z-1814-2025Open, ClassifiedSunMed Holdings, LLC
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
Z-1057-2024Open, ClassifiedVyaire Medical, Inc.
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Z-1058-2024Open, ClassifiedVyaire Medical, Inc.
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Showing the 5 most recently initiated of 97. 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 BTM?
MAUDE holds 109 adverse-event reports naming product code BTM, 30 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 BTM unusual?
BTM does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history |
31 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.
What are the predicate devices in BTM?
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 BTM?
Across the 209 most recent decisions, these applicants filed most often in BTM.
| Applicant | Recent clearances |
|---|---|
| Ambu, Inc. | 15 |
| Puritan Bennett Corp. | 12 |
| Medical Marketing Concepts | 11 |
| Life Design Systems, Inc. | 7 |
| Engineered Medical Systems | 6 |
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 BTM 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 |
|---|---|---|
| Puritan Bennett Corporation | 13 | 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 BTM
Get an email the morning anything changes in BTM — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Anesthesiology
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.