510(k) · Cleared
ClearedThe BAG manual resuscitator and accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laerdal Medical AS · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Nov 24, 2025 after a 180-day review. The summary cites 3 numbers, none of which could be confirmed as its predicate (see the table below).
- Decided
- Nov 24, 2025
- Review
- 180 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 3
The summary cites 3 numbers, none of which could be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTM device
- #1 K243861 butterflyBVMscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K183831 | The BAG manual resuscitator (Laerdal Medical AS) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K163060 | FDA’s K163060 is Deep Conical (DC) Implants and Accessories Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2017 |
| Kept off the family tree | K110277 | FDA’s K110277 is Rapidpoint 405 Neonatal Bilirubin Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments. The sizes versions also include indications for the patient population: Adult: The Adult model is intended for patients over 20 kg (44 Ibs). Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44…
Read the full statement (190 words)
The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.
The sizes versions also include indications for the patient population:
Adult: The Adult model is intended for patients over 20 kg (44 Ibs).
Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 Ibs).
Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 Ibs).
The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.
The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251631: The BAG manual resuscitator and accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251631
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026