# K053140: Ambu Mark IV Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Dec 23, 2005 after 44 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ambu® SIR 2 (Silicone Resuscitator), Adult: named in the summary without a submission number
- (no number) Ambu® Mark III Resuscitator: named in the summary without a submission number
- (no number) Ambu® SPUR® II Adult: named in the summary without a submission number

## Most influential descendants
- K092085: Ispira Resuscitation Unit (2009), 4 descendants of its own
- K102649: Neopop Infant Resuscitator with Flow Meter (2011), 2 descendants of its own
- K110119: Pressure Manometer (2011), 1 descendant of its own
- K142096: T-Piece Resuscitator (2014), 0 descendants of its own
- K122627: Gio Digital Pressure Guages (2013), 0 descendants of its own

## Indications for use
Ambu® Mark IV Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of patients with a body weight of more than 33 lbs (15 kg., approx. 3 years of age. Ambu Mark IV Resuscitator is a reusable resuscitator.

Source page: https://510kreport.com/device/K053140
Methodology: https://510kreport.com/methodology