# K023494: Nellcor Indgo Manual Resuscitator

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Feb 7, 2003 after 112 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: 3 generations back to K894053 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973419: DMR Plus Disposable Manual Resuscitator, Nellcor Puritan Bennett, Inc. (1998) Summary page 1.

## Indications for use
The Nellcor INdGO Manual Resuscitator is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The Nellcor INdGO Manual Resuscitator is available with or without an integrated CO2 detector. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison. The Nellcor INdGO Manual Resuscitator is available in two sizes and is for use on the following patient populations: Adult size is for use on adults > 30kg. Child size is for use on children 10 - 30 kg. The Nellcor INdGO Manual Resuscitator is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home. This device is for prescription use only.

Source page: https://510kreport.com/device/K023494
Methodology: https://510kreport.com/methodology