510(k) · Cleared
ClearedRusch Manual Resuscitator Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Mar 24, 2000 as substantially equivalent to K924610 (Engineered Medical Systems, 1993) after a 183-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Mar 24, 2000
- Review
- 183 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924610 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK924610 Baxter Adult/Pedi/Infant Single Use Man ResuscitEngineered Medical Systems · 1993 · Recalled
- This deviceK993194 Rusch Manual Resuscitator BagRusch, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924610 | Baxter Adult/Pedi/Infant Single Use Man Resuscit | Engineered Medical Systems | 1993 | 1 |
| 0 (this device) | K993194 | Rusch Manual Resuscitator Bag | Rusch, Inc. | 2000 | — |
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? (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 |
|---|---|---|---|
| * | K924610 | Baxter Adult/Pedi/Infant Single Use Man ResuscitSummary page 1…Manual Resuscitator Bag Classification Name: Manual Emergency Ventilator (Resuscitator) Predicate Legally Marketed Device: Baxter Adult/ Pedi/ Infant Resuscitator Bag: K924610 Page 1 of 2 PAGS £ 2 oF DESCRIPTION OF THE DEVICE The product consists of a face mask, bag, valve, reservoir b… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K924610.
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 Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen
The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively
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/K993194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993194: Rusch Manual Resuscitator Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993194
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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