510(k) · Cleared
Recalled · Class I · 2015Hudson Rci Lifesaver Single Patient Use Manual Resuscitator
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 Feb 21, 1997 as substantially equivalent to K911465 (Vital Signs, Inc., 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Feb 21, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- BTM
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911465 (1991). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK911465 Infant/Pediatric Resuscitation Circuit W/AplVital Signs, Inc. · 1991
- This deviceK964719 Hudson Rci Lifesaver Single Patient Use Manual ResuscitatorHudson Respiratory Care, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911465 | Infant/Pediatric Resuscitation Circuit W/Apl | Vital Signs, Inc. | 1991 | — |
| 0 (this device) | K964719 | Hudson Rci Lifesaver Single Patient Use Manual Resuscitator | Hudson Respiratory Care, Inc. | 1997 | — |
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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K911465 | Infant/Pediatric Resuscitation Circuit W/AplSummary page 1…Ventilator, emergency, manual (resuscitator) Common Name Resuscitation Bag or Resuscitator Predicate Device Infant/Pediatric Resuscitation Circuit Vital Signs, Inc. K911465 Device Description The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator is a disposable, single patient use, medical… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2015 | Class I | Z-1809-2015 | Nonconforming Material/Component | The intake port may be blocked which can cause the bag to fail to fill. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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 Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure. The Hudson RCI Lifesaver Single Patient Use Manual…
Read the full statement (148 words)
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure.
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a “back-up” ventilation system in the event of mechanica! ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.
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/K964719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964719: Hudson Rci Lifesaver Single Patient Use 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/K964719
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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