510(k) · Cleared
ClearedDisposable Manual Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan-Bennett · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Aug 11, 1994 after a 15-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Aug 11, 1994
- Review
- 15 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK943617 Disposable Manual ResuscitatorPuritan-Bennett · 1994
- Descendant · cites it directly · 6 of its ownK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
- Descendant · 2 generations on · 5 of its ownK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
- Descendant · 3 generations on · 1 of its ownK021328 Smart Bag MOO-Two Systems International, Inc. · 2003
- Descendant · 4 generations on · 0 of its ownK212905 Sotair DeviceSafe Bvm Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK023494 Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc. · 2003
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K960468DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996 · cites it directly6descendants
- K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998 · 2 generations on5descendants
- K021328Smart Bag MOO-Two Systems International, Inc. · 2003 · 3 generations on1descendant
- K212905Sotair DeviceSafe Bvm Corporation · 2022 · 4 generations on0descendants
- K023494Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc. · 2003 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943617 | Disposable Manual Resuscitator | Puritan-Bennett | 1994 | — |
| +1 | K960468 | DMR/CO2 Combo Kti | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +2 | K973419 | DMR Plus Disposable Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 1998 | — |
| +3 | K021328 | Smart Bag MO | O-Two Systems International, Inc. | 2003 | — |
| +4 | K212905 | Sotair Device | Safe Bvm Corporation | 2022 | — |
| +3 | K023494 | Nellcor Indgo Manual Resuscitator | Nellcor Puritan Bennett, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960468 | DMR/CO2 Combo Kti | 1996 | 6 |
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?
- Of its descendants, K960468 (Nellcor Puritan Bennett, Inc., 1996) has gone furthest, with 6 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) | — |
https://510kreport.com/device/K943617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943617: Disposable Manual Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943617
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026