510(k) · Cleared
ClearedbutterflyBVM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compact Medical, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Apr 25, 2025 as substantially equivalent to K152931 (Ambu A/S, 2016) after a 130-day review. Its family tree reaches back 2 generations to 2004. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 25, 2025
- Review
- 130 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042843 (2004). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK042843 Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc. · 2004 · Recalled
- 1 generation backK152931 Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric…Ambu A/S · 2016 · Recalled (Class I)
- This deviceK243861 butterflyBVMCompact Medical, Inc. · 2025
Class I recalls in this family
- K152931 Ambu SPUR II Adult Resuscitator, Ambu SPUR II…direct predicate · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042843 | Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators | Ambu, Inc. | 2004 | 1 |
| −1 | K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu… | Ambu A/S | 2016 | Class I |
| 0 (this device) | K243861 | butterflyBVM | Compact Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 K221841 EOlife®score 5.0 · 1 generation · 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 |
|---|---|---|---|
| * | K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…Summary page 5…510(k) Number Predicate Device Name / Manufacturer Primary Predicate K152931 Spur II/Ambu DEVICE DESCRIPTION The butterflyBVM™ is a three-in-on… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorAmbu A/S · 2016 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I 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. 2025, this device’s year, is highlighted.
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 butterflyBVMTM when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates.
The butterflyBVMTM when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243861: butterflyBVM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243861
Report an extraction error
Are you the manufacturer?
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