← Product Code [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM) · K960468 # DMR/CO2 COMBO KTI (K960468) _Nellcor Puritan Bennett, Inc. · BTM · Apr 26, 1996 · Anesthesiology · SESK_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K960468 ## Device Facts - **Applicant:** Nellcor Puritan Bennett, Inc. - **Product Code:** [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM.md) - **Decision Date:** Apr 26, 1996 - **Decision:** SESK - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5915 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic, Pediatric ## Indications for Use 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 lbs.). 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 when 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. ## Device Story DMR/CO2 Combo Kit combines a bag-valve-mask manual resuscitator with a colorimetric end-tidal CO2 (EtCO2) detector. Resuscitator delivers ambient or oxygen-enriched air via mask or endotracheal tube. EtCO2 detector connects between endotracheal tube and breathing circuit; utilizes chemical color-change indicator to provide visual estimation of CO2 ranges. Used by clinicians in clinical settings or patient transport to verify tube placement and monitor ventilation status. Provides immediate visual feedback to clinicians; assists in confirming correct airway placement and assessing patient respiratory status during emergencies like cardiac arrest. Single-patient, disposable use; limited to two-hour duration. ## Clinical Evidence No clinical data provided; device relies on the established safety and effectiveness of the individual predicate components. ## Technological Characteristics Kit consists of a bag-valve-mask resuscitator and colorimetric CO2 detectors. Detectors use chemical color-change indicators for CO2 sensing. Non-sterile, single-patient use, disposable. No electronic components or software. ## Regulatory Identification A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. ## Predicate Devices - Nellcor Puritan Bennett Disposable Manual Resuscitator (DMR) ([K943617](/device/K943617.md)) - Nellcor Puritan Bennett Easy Cap End-Tidal CO2 Detector ([K894053](/device/K894053.md)) - Nellcor Puritan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector ([K944400](/device/K944400.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 16. 510(k) SUMMARY K960468 January 31, 1996 APR 26 1996 # 1. COMPANY INFORMATION Establishment: Puritan-Bennett Corp. 9728 Pflumm Road Lenexa, KS 66285-5915 Official Correspondent: C. Marshall Smith Project Manager, Regulatory Affairs # 2. KIT NAME Proprietary: DMR/CO2 Combo Kit Common/Usual: Disposable Manual Resuscitator and CO2 Detector Classification: Kit unclassified # 3. EQUIVALENT DEVICE The DMR/CO2 Combo Kit is comprised of the following devices: - Nellcor Puritan Bennett Disposable Manual Resuscitator (DMR) K943617; and either - Nellcor Puritan Bennett Easy Cap End-Tidal CO2 Detector K894053, or - Nellcor Puritan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector - K944400 These devices have been found to be substantially equivalent through the premarket notification process. # 4. DEVICE DESCRIPTION The DMR/CO2 Combo Kit is comprised of the following devices: Nellcor Puritan Bennett 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. It is a non-sterile, single-patient use device. DMR/CO2 Combo Kit 55 January 31, 1996 {1} Nellcor Puritan Bennett DMR/O2 Combo Kit 510(k) Summary Page 2 Nellcor Puritan Bennett 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 lbs.). 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. Nellcor Puritan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector detects approximate ranges of end-tidal CO2 by color comparison in patients weighing 1 to 15 kg (2.2 to 33 lbs.). 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. It may be used during patient transport or in any location where intubations are performed. It is a non-sterile, disposable, single use end-tidal CO2 detector which may be used for up to two hours. ## 5. INTENDED 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 lbs.). 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. DMR/CO2 Combo Kit 56 January 31, 1996 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K960468](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K960468) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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