510(k) · Cleared
ClearedDMR Plus Disposable Manual Resuscitator
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 Mar 25, 1998 as substantially equivalent to K933626 (Kirk Specialty Systems, 1993) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 1989. 5 later devices descend from it.
- Decided
- Mar 25, 1998
- Review
- 196 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894053 (1989). 5 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- 1 generation backK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
- This deviceK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK021328 Smart Bag MOO-Two Systems International, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK212905 Sotair DeviceSafe Bvm Corporation · 2022
- Descendant · cites it directly · 0 of its ownK023494 Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK991955 Modification to Engineered Medical Systems Disposable Manual…Engineered Medical Systems · 1999
- Descendant · cites it directly · 0 of its ownK991953 Modification to Engineered Medical Systems Disposable Manual…Engineered Medical Systems · 1999
Most influential descendants
Showing 5 of 5 · See all- K021328Smart Bag MOO-Two Systems International, Inc. · 2003 · cites it directly1descendant
- K212905Sotair DeviceSafe Bvm Corporation · 2022 · 2 generations on0descendants
- K023494Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc. · 2003 · cites it directly0descendants
- K991955Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems · 1999 · cites it directly0descendants
- K991953Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| −1 | K960468 | DMR/CO2 Combo Kti | Nellcor Puritan Bennett, Inc. | 1996 | — |
| 0 (this device) | K973419 | DMR Plus Disposable Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 1998 | — |
| +1 | K021328 | Smart Bag MO | O-Two Systems International, Inc. | 2003 | — |
| +2 | K212905 | Sotair Device | Safe Bvm Corporation | 2022 | — |
| +1 | K023494 | Nellcor Indgo Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 2003 | — |
| +1 | K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with… | Engineered Medical Systems | 1999 | — |
| +1 | K991953 | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K933626 | Capno-FloSummary page 1…ble Manual Resuscitator with integrated CO2 detection Classification: 73BTM 3. Equivalent Device 1. CAPNO-FLO™ End-Tidal CO2 Detector/Monitor - Kirk Specialty Systems - K933626 2. Nellcor Puritan Bennett DMR/CO2 Combo Kit - K860468 4, Device Description The DMR? Plus™ Disposable Manual Resuscitator wit… | 1993 |
| * | K960468 | DMR/CO2 Combo Kti 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”. | 1996 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K021328 (O-Two Systems International, Inc., 2003) has gone furthest, with 1 descendant 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 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…
Read the full statement (171 words)
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.
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/K973419 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973419: DMR Plus Disposable Manual Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973419
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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