510(k) · Decided
DecidedDMR/CO2 Combo Kti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Apr 26, 1996 as substantially equivalent to K943617 (Puritan-Bennett, 1994) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1989. 6 later devices descend from it.
- Decided
- Apr 26, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894053 (1989). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- This deviceK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK021328 Smart Bag MOO-Two Systems International, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK212905 Sotair DeviceSafe Bvm Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK023494 Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK991955 Modification to Engineered Medical Systems Disposable Manual…Engineered Medical Systems · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998 · cites it directly5descendants
- K021328Smart Bag MOO-Two Systems International, Inc. · 2003 · 2 generations on1descendant
- K212905Sotair DeviceSafe Bvm Corporation · 2022 · 3 generations on0descendants
- K023494Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc. · 2003 · 2 generations on0descendants
- K991955Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| 0 (this device) | K960468 | DMR/CO2 Combo Kti | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +1 | K973419 | DMR Plus Disposable Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 1998 | — |
| +2 | K021328 | Smart Bag MO | O-Two Systems International, Inc. | 2003 | — |
| +3 | K212905 | Sotair Device | Safe Bvm Corporation | 2022 | — |
| +2 | K023494 | Nellcor Indgo Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 2003 | — |
| +2 | K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with… | Engineered Medical Systems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTM device
- #1 K243861 butterflyBVMscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943617 | Disposable Manual ResuscitatorSummary page 1…ion: Kit unclassified 3. EQUIVALENT DEVICE The DMR/CO2 Combo Kit is comprised of the following devices: » Nellcor Punitan Bennett Disposable Manual Resuscitator (ODMR) K943617; and either e Nellcor Puritan Bennett Easy Cap End-Tidal CO2 Detector K894053, or * Nellcor Puntan Bennett Pedi-Cap Pediatric E… | 1994 |
| * | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 DetectorSummary page 1…of the following devices: » Nellcor Punitan Bennett Disposable Manual Resuscitator (ODMR) K943617; and either e Nellcor Puritan Bennett Easy Cap End-Tidal CO2 Detector K894053, or * Nellcor Puntan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector - K844400 These devices have been found to be substantia… | 1989 |
| * | K944400 | Pedi-Cap 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”. | 1994 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973419 | DMR Plus Disposable Manual Resuscitator | 1998 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K973419 (Nellcor Puritan Bennett, Inc., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
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…
Read the full statement (234 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960468: DMR/CO2 Combo Kti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960468
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026