510(k) Report

510(k) · Cleared

Cleared

Ambu Oval Silicone Resuscitator, Adult and Pediatric

K102824510(k) AbbreviatedCleared Jan 28, 2011121-day reviewClass II21 CFR 868.5915

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 Jan 28, 2011 as substantially equivalent to K910040 (Ambu, Inc., 1991) and 3 other predicates after a 121-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jan 28, 2011
Review
121 days
Class
Class II
Product code
BTM
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K910040 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors1991: 1 other ancestorK910040 · Ambu Sir 2 (Silicone Resuscitator), Adult · Ambu, Inc. · 199119901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors K910040 · Ambu Sir 2 (Silicone Resuscitator), Adult · Ambu, Inc. · 19910
  1. Root · 1 generation backK910040 Ambu Sir 2 (Silicone Resuscitator), AdultAmbu, Inc. · 1991
  2. This deviceK102824 Ambu Oval Silicone Resuscitator, Adult and PediatricAmbu A/S · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K910040Ambu Sir 2 (Silicone Resuscitator), AdultAmbu, Inc.1991—
0 (this device)K102824Ambu Oval Silicone Resuscitator, Adult and PediatricAmbu A/S2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200520
FIG. 1 — Lineage of K102824, 1991–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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. #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? (4)

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
*K910040Ambu Sir 2 (Silicone Resuscitator), Adult
Summary page 1
…lly equivalent: Ambu Oval Resuscitator, Adlt Manufacturer I Trade Name 510(k) numbe Am bu Sliconel Resuscitator, Adult K910040 Ambu IMark IV Resuscitator, AdultK534 Ambu Oval Resuscitator. Pediatric Manufacturer ITrade Name…
Ambu, Inc.1991—
*K053140Ambu Mark IV Resuscitator
Summary page 3
…dicate devices Ambu Oval Resuscitators, Adult is substantially equivalent to: * Ambu Silicone Resuscitator, Adult (K910040) * Ambu Mark IV Resuscitator, Adult (K053140) The operation and technological characteristics of Ambu Oval Resuscitator, Adult is the same as the predicate devices operation…
Ambu A/S2005—
*K914187Ambu Silicone Resuscitator Infant/Child
Summary page 3
…is substantially equivalent to the predicate devices. Ambu Oval Resuscitators, Pediatric is substantially equivalent to: * Ambu Silicone Resuscitator, Infant/Child (K914187) * Ambu Mark IV Resuscitator, Baby (K053142) The operation and technological characteristics of Ambu Oval Resuscitator, Pedi…
Ambu, Inc.1991—
*K053142Ambu Mark IV Baby Resuscitator
Summary page 3
…ces. Ambu Oval Resuscitators, Pediatric is substantially equivalent to: * Ambu Silicone Resuscitator, Infant/Child (K914187) * Ambu Mark IV Resuscitator, Baby (K053142) The operation and technological characteristics of Ambu Oval Resuscitator, Pediatric is the same as the predicate devices operat…
Ambu A/S2005—

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?

  • None of the 4 ancestors has a recall.

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. 2011, 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® Oval Silicone resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. For use by CPR-trained personnel only, in hospital and pre-hospital settings.

The Ambu Oval Silicone resuscitator is reusable. The range of application for the sizes are:

Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.).

Paediatric: Infants and children with a body weight between approx. 10-30 kg (22-66 lbs.)

Indications for use as stated in the FDA summary.

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/K102824 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102824: Ambu Oval Silicone Resuscitator, Adult and Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102824

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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