510(k) · Cleared
Recalled · Class II · 2014Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Nov 12, 2004 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 12, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- BTM
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK042843 Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK152931 Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric…Ambu A/S · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK243861 butterflyBVMCompact Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK181583 Adult Single Use Resuscitator Bag without Pressure Relief, Adult…Flexicare Medical Limited. · 2018
- Descendant · cites it directly · 0 of its ownK094003 RevivatorHersill, S.L. · 2010
Class I recalls in this family
- K152931 Ambu SPUR II Adult Resuscitator, Ambu SPUR II…cites it directly · 2016
Most influential descendants
Showing 4 of 4 · See all- K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…Ambu A/S · 2016 · cites it directly1descendant
- K243861butterflyBVMCompact Medical, Inc. · 2025 · 2 generations on0descendants
- K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…Flexicare Medical Limited. · 2018 · cites it directly0descendants
- K094003RevivatorHersill, S.L. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042843 | Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators | Ambu, Inc. | 2004 | — |
| +1 | K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu… | Ambu A/S | 2016 | Class I |
| +2 | K243861 | butterflyBVM | Compact Medical, Inc. | 2025 | — |
| +1 | K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use… | Flexicare Medical Limited. | 2018 | — |
| +1 | K094003 | Revivator | Hersill, S.L. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 1 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2014 | Class II | Z-2086-2014 | Component design/selection | The femoral stem is lacking specified plasma coating. |
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 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K152931 (Ambu A/S, 2016) has gone furthest, with 1 descendant 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) | — |
What is it indicated for?
The Arnbu SPUR Ill Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 221bs (10kg).
The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 661bs (30kg), approx. 9 years of age.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042843 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042843
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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