# K094003: Revivator

- Pathway: 510(k) (Abbreviated)
- Applicant: Hersill, S.L.
- Decided: Sep 17, 2010 after 263 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
Longest line of descent: 2 generations back to K911622 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993278: Ambu Neonate Silicone Resuscitator, Ambu, Inc. (2000) Summary page 1.
- K924215: Ambu Silicone Resuscitator, Adult W/Open Reservoir, Ambu, Inc. (1992) Summary page 2.
- K924216: Ambu Silicone Resuscitator Infan/Child W/Open Reso, Ambu, Inc. (1992) Summary page 2.
- K042682: Ambu Spur II. Adult Single Patient Resuscitator, Ambu, Inc. (2004) Summary page 2.
- K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators, Ambu, Inc. (2004) Summary page 2.
- K911622: CPR Bag, Merced Medical, Inc. (1991) Summary page 2.
- K970756: Mercury Medical Reusable CPR Bag, Mercury Medical (1997) Summary page 2.

## Indications for use
The Revivator resuscitator is intended for pulmonary resuscitation. The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs) The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs) The infant resuscitator isfor infants with a body weight up to 7 kg (15 lbs)

Source page: https://510kreport.com/device/K094003
Methodology: https://510kreport.com/methodology