# K991861: 1ST Response Infant Manual Resuscitator, Bag Resevoir, 1ST Response Pediatric Manual Resuscitator, Bag Reservoir, 1ST RE

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Jan 18, 2000 after 231 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 FDA summary names its predicate without a number.
- (no number) Hudson Respiratory Care Inc. Neonate Manual Resuscitator, Cat. No. 5360: named in the summary without a submission number
- (no number) Hudson Respiratory Care Inc. Pediatric Manual Resuscitator, Cat. No. 5365: named in the summary without a submission number
- (no number) SIMS Portex Inc. 1* Response Infant Manual Resuscitator, Cat. No. 008027MP: named in the summary without a submission number
- (no number) SIMS Portex Inc. 1* Response Pediatric Manual Resuscitator, Cat. No. 008120: named in the summary without a submission number

## Indications for use
Infant Manual Resuscitator The 1* Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of < 10 kg (22 Ibs). Pediatric Manual Resuscitator The 1* Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to pediatric patients suffering from respiratory distress. It is intended for use on patients with a body mass of > 10 kg (22 Ibs) and <25 kg (55 1bs).

Source page: https://510kreport.com/device/K991861
Methodology: https://510kreport.com/methodology