# K960468: DMR/CO2 Combo Kti

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Apr 26, 1996 after 85 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: 1 generation back to K894053 (1989). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943617: Disposable Manual Resuscitator, Puritan-Bennett (1994) Summary page 1.
- K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector, Fenem, Inc. (1989) Summary page 1.
- K944400: Pedi-Cap, Nellcor, Inc. (1994). Our OCR of the scanned summary read K844400, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nellcor Puritan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector”.

## Most influential descendants
- K973419: DMR Plus Disposable Manual Resuscitator (1998), 5 descendants of its own
- 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

## Indications for use
The inclusion of the following components in the DMR/CO2 Combo Kit does not alter the intended use of the individual components in any way. The Disposable Manual Resuscitator (DMR) is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by extending the oxygen accumulator and connecting supply tubing to a metered oxygen source. The Easy Cap detector, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients weighing more than 15 kg (33 Ibs.). The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to two hours. The Easy Cap detector assists verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant. The Pedi-Cap detector detects approximate ranges of end-tidal CO2 by color comparison. It is intended for use during endotracheal or nasotracheal intubation to assist verification of tube placement. It is also intended for use on intubated patients where measuring approximate ranges of end-tidal CO2 may be clinically significant and other more precise methods are not feasible or available, i.e., during cardiac arrest or respiratory insufficiency. The Pedi-Cap detector connects to an endotracheal tube and a breathing device.

Source page: https://510kreport.com/device/K960468
Methodology: https://510kreport.com/methodology