# K251631: The BAG manual resuscitator and accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laerdal Medical AS
- Decided: Nov 24, 2025 after 180 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but 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
- K163060: Deep Conical (DC) Implants and Accessories, Southern Implants (Pty), Ltd. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K110277: Rapidpoint 405 Neonatal Bilirubin, Siemens Healthcare Diagnostics (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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.

Source page: https://510kreport.com/device/K251631
Methodology: https://510kreport.com/methodology