# K992057: Ist Response Manual Resuscitator, Models, 008000, 008003,008006

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Sep 13, 1999 after 87 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) SIMS Portex Inc. 1st Response Adult Manual Resuscitators, Cat. No. 008000, 008003, and 008006: named in the summary without a submission number
- (no number) Laerdal Silicone Resuscitator, Adult: named in the summary without a submission number

## Most influential descendants
- K014115: 1ST Response Manual Resuscitator, Model 85XX (2002), 0 descendants of its own

## Indications for use
The 1st Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 lbs) or more.

Source page: https://510kreport.com/device/K992057
Methodology: https://510kreport.com/methodology