510(k) Report

510(k) · Cleared

Recalled · Class I · 2025

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

K152931510(k) AbbreviatedCleared Aug 29, 2016329-day reviewClass II21 CFR 868.5915Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ambu A/S · BTM Ventilator, Emergency, Manual (Resuscitator)

Cleared on Aug 29, 2016 as substantially equivalent to K042682 (Ambu, Inc., 2004) and 1 other predicate after a 329-day review. Its family tree reaches back 1 generation to 2004. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.

Decided
Aug 29, 2016
Review
329 days
Class
Class II
Product code
BTM
Recalls
1 (1 Class I)
Predicates
2

Its longest line of descent runs back 1 generation to K042843 (2004). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2025: 1 descendant clearedK042843 · Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators · Ambu, Inc. · 2004 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K042843 · Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators · Ambu, Inc. · 2004 · recalled0
  1. Root · 1 generation backK042843 Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc. · 2004 · Recalled
  2. This deviceK152931 Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric…Ambu A/S · 2016
  3. Descendant · cites it directly · 0 of its ownK243861 butterflyBVMCompact Medical, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243861butterflyBVMCompact Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K042843Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc.20041
0 (this device)K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu…Ambu A/S2016—
+1K243861butterflyBVMCompact Medical, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K152931, 2004–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243861 butterflyBVMscore 9.5 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042682Ambu Spur II. Adult Single Patient Resuscitator
Summary page 5
…510k Product number code AMBU A/S Ambu® SPUR® II Adult K042682 BTM Ambu SPUR II Pediatric Resuscitator: Manufacturer Trade Name 510k…
Ambu, Inc.2004—
*K042843Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators
Summary page 5
…10k Product number code AMBU A/S Ambu® SPUR® II Pediatric K042843 BTM Ambu SPUR II Infant Resuscitator: Manufacturer Trade Name 510k P…
Ambu, Inc.20041

Also cleared against K042682: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K243861butterflyBVMCompact Medical, Inc.20250

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 9, 2025Class IZ-2181-2025Equipment maintenancePotential for the manometer port being blocked rendering the manometer non-functional.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K243861 (Compact Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K042682.

How does its category compare?

All BTM devices

BTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · BTM

2in 2025

2007: 22008: 32010: 22011: 22012: 12015: 12016: 12018: 22021: 12022: 12023: 12025: 22026 (partial year): 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTM

83in 2008

2008: 83 days median
2007high 83 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BTM

9in 2024

2009: 232010: 32012: 13, 13 Class I2013: 3, 1 Class I2023: 92024: 9, 9 Class I2026 (partial year): 1, 1 Class I
2007high 23 (2009) · low 0 (2007)2026

Class I (24 since 2007) Class II/III not classified

Adverse event reports per year · BTM

36in 2025

2007: 652008: 312009: 212010: 232011: 482012: 692013: 442014: 1082015: 362016: 922017: 562018: 562019: 462020: 262021: 422022: 352023: 462024: 332025: 36
2007high 108 (2014) · low 21 (2009)2025

MAUDE reports naming product code BTM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—065
2008383031
20090—2321
20102—323
20112—048
20121—13 (13)69
20130—3 (1)44
20140—0108
20151—036
20161—092
20170—056
20182—056
20190—046
20200—026
20211—042
20221—035
20231—946
20240—9 (9)33
20252—036
20261—1 (1)—

What is it indicated for?

The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation.

The range of the application for each version is:

- Adult: Adults and children with a body weight more than 30kg (66lb).

- Pediatric: Infant and children with a body weight up to 30kg (66lb).

- Infant: Neonates and infant with a body weight up to 10kg (22lb).

Indications for use as stated in the FDA summary.

Also cleared against K042682

3 other devices cite the same predicate.

  • K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure…Flexicare Medical Limited. · 2018
  • K094003RevivatorHersill, S.L. · 2010
  • K093081Pocket BVMMicrobvm Systems, Ltd. · 2010

More from Ambu A/S

41 FDA decisions under this applicant name. See the company

  • K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
  • K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026
  • K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)Ambu A/S · 2025

Recent decisions in BTM

The BTM category page

  • K263254Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)Xiamen Compower Medical Tech. Co., Ltd. · 2026
  • K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS · 2025
  • K243861butterflyBVMCompact Medical, Inc. · 2025
  • K221841EOlife®Archeon · 2023
  • K212905Sotair DeviceSafe Bvm Corporation · 2022

https://510kreport.com/device/K152931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152931: Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152931

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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