510(k) · Cleared
ClearedHudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hudson Respiratory Care, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Dec 21, 1994 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 21, 1994
- Review
- 106 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK944301 Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog…Hudson Respiratory Care, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK082092 Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve…Galemed Corp. · 2008
- Descendant · 2 generations on · 1 of its ownK170663 Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP…Foremount Enterprise Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK090317 Babi*Plus Bubble Pap ValveA Plus Medical · 2009
- Descendant · 3 generations on · 0 of its ownK210288 Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK133957 Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K082092Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…Galemed Corp. · 2008 · cites it directly6descendants
- K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…Foremount Enterprise Co., Ltd. · 2018 · 2 generations on1descendant
- K090317Babi*Plus Bubble Pap ValveA Plus Medical · 2009 · 2 generations on1descendant
- K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. · 2021 · 3 generations on0descendants
- K133957Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944301 | Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers… | Hudson Respiratory Care, Inc. | 1994 | — |
| +1 | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable… | Galemed Corp. | 2008 | — |
| +2 | K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve… | Foremount Enterprise Co., Ltd. | 2018 | — |
| +2 | K090317 | Babi*Plus Bubble Pap Valve | A Plus Medical | 2009 | — |
| +3 | K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021 | — |
| +2 | K133957 | Disposable Adjustable Peep Valve MR Conditional Use | Galemed Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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?
- Of its descendants, K082092 (Galemed Corp., 2008) 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/K944301 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944301: Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944301
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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