# K014115: 1ST Response Manual Resuscitator, Model 85XX

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Inc.
- Decided: Feb 27, 2002 after 75 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992057 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992057: Ist Response Manual Resuscitator, Models, 008000, 008003,008006, Sims Portex, Inc. (1999) Summary page 1.

## Recalls of this device
- Nov 15, 2002 · Not classified · Z-0808-03: Peep valve set at the highest level and could result in patient injury
- Nov 15, 2002 · Not classified · Z-0809-03: Peep valve set at the highest level and could result in patient injury
- Nov 15, 2002 · Not classified · Z-0810-03: Peep valve set at the highest level and could result in patient injury

## Indications for use
The 1* 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 Ibs) or more.

Source page: https://510kreport.com/device/K014115
Methodology: https://510kreport.com/methodology