510(k) · Cleared
Recalled · Class II · 2013Baxter Adult/Pedi/Infant Single Use Man Resuscit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Apr 6, 1993 after a 207-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 6, 1993
- Review
- 207 days
- Class
- Class II
- Product code
- BTM
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK924610 Baxter Adult/Pedi/Infant Single Use Man ResuscitEngineered Medical Systems · 1993
- Descendant · cites it directly · 0 of its ownK993194 Rusch Manual Resuscitator BagRusch, Inc. · 2000
- 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 3 of 3 · See all- K993194Rusch Manual Resuscitator BagRusch, Inc. · 2000 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K924610 | Baxter Adult/Pedi/Infant Single Use Man Resuscit | Engineered Medical Systems | 1993 | — |
| +1 | K993194 | Rusch Manual Resuscitator Bag | Rusch, Inc. | 2000 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 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? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2013 | Class II | Z-1947-2013 | Nonconforming Material/Component | CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993194 (Rusch, Inc., 2000) has gone furthest, with 0 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/K924610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924610: Baxter Adult/Pedi/Infant Single Use Man Resuscit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924610
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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