# K973419: DMR Plus Disposable Manual Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Mar 25, 1998 after 196 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 K894053 (1989). 5 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933626: Capno-Flo, Kirk Specialty Systems (1993) Summary page 1.
- K960468: DMR/CO2 Combo Kti, Nellcor Puritan Bennett, Inc. (1996). Our OCR of the scanned summary read K860468, FDA’s number for Unicaddy I & II I.V. Container Caddy Ims Pole Mate (Intl. Medication Systems, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nellcor Puritan Bennett DMR/CO2 Combo Kit”.

## Most influential descendants
- K021328: Smart Bag MO (2003), 1 descendant of its own
- K212905: Sotair Device (2022), 0 descendants of its own
- K023494: Nellcor Indgo Manual Resuscitator (2003), 0 descendants of its own
- K991955: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection (1999), 0 descendants of its own
- K991953: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection (1999), 0 descendants of its own

## Indications for use
The DMR? Plus™ Disposable Manual Resuscitator with integrated CO2 detection 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 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 DMR? Plus™ is available in three sizes and is for use on the following patient populations: e Adult is indicated for use on adults >40 kg. ¢ Child is indicated for use on children 10 - 40 kg. ¢ Infant is indicated for use on infants 5 - 10 kg The DMR? Plus™ Disposable Manual Resuscitator with integrated CO2 detection is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.

Source page: https://510kreport.com/device/K973419
Methodology: https://510kreport.com/methodology