510(k) · Cleared

Cleared

Revivator

K094003510(k) AbbreviatedCleared Sep 17, 2010263-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

Hersill, S.L. · BTM Ventilator, Emergency, Manual (Resuscitator)

Cleared on Sep 17, 2010 as substantially equivalent to K993278 (Ambu, Inc., 2000) and 6 other predicates after a 263-day review. Its family tree reaches back 2 generations to 1991.

Decided: Sep 17, 2010
Review: 263 days
Class: Class II
Product code: BTM
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K911622 (1991). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK911622 CPR BagMerced Medical, Inc. · 1991
1 generation backK970756 Mercury Medical Reusable CPR BagMercury Medical · 1997
This deviceK094003 RevivatorHersill, S.L. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911622	CPR Bag	Merced Medical, Inc.	1991	—
−1	K970756	Mercury Medical Reusable CPR Bag	Mercury Medical	1997	—
0 (this device)	K094003	Revivator	Hersill, S.L.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0
2000	1	0
2004	2	0

FIG. 1 — Lineage of K094003, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K993278	Ambu Neonate Silicone Resuscitator Summary page 1 …en found to be substantially equivalent through the 510(k) premarket notification process; Submiter: Ambu, Inc. *Ambu neonate silicone resuscitator (K993278) -5. 1 - - .. i…	Ambu, Inc.	2000	—
*	K924215	Ambu Silicone Resuscitator, Adult W/Open Reservoir Summary page 2 …ENISOa~~MM N ToI vf391 61 641 1I-Fpox 34 91 615 48 92 ww.hers1Ilcorn 5. "5 10(k) SUMMARY" * Ambu silicone resuscitator adult (K9242 15) * Ambu silicone infant/child (K9242 16) * Ambu spur II adult single patient resuscitator (K04268…	Ambu, Inc.	1992	—
*	K924216	Ambu Silicone Resuscitator Infan/Child W/Open Reso Summary page 2 …91 615 48 92 ww.hers1Ilcorn 5. "5 10(k) SUMMARY" * Ambu silicone resuscitator adult (K9242 15) * Ambu silicone infant/child (K9242 16) * Ambu spur II adult single patient resuscitator (K042682) * Ambu Spur II infant and paediatric…	Ambu, Inc.	1992	—
*	K042682	Ambu Spur II. Adult Single Patient Resuscitator Summary page 2 …Ambu silicone resuscitator adult (K9242 15) * Ambu silicone infant/child (K9242 16) * Ambu spur II adult single patient resuscitator (K042682) * Ambu Spur II infant and paediatric single (K042843) Submitter: Mercury Medical * Mercury me…	Ambu, Inc.	2004	—
*	K042843	Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators Summary page 2 …silicone infant/child (K9242 16) * Ambu spur II adult single patient resuscitator (K042682) * Ambu Spur II infant and paediatric single (K042843) Submitter: Mercury Medical * Mercury medical disposable CPR bag (K91 1622) * Mercury medical…	Ambu, Inc.	2004	1
*	K911622	CPR Bag Summary page 2 …tator (K042682) * Ambu Spur II infant and paediatric single (K042843) Submitter: Mercury Medical * Mercury medical disposable CPR bag (K91 1622) * Mercury medical reusable CPR bag (K970756) (4) Device description Functioningz and scientific concerts A…	Merced Medical, Inc.	1991	—
*	K970756	Mercury Medical Reusable CPR Bag Summary page 2 …atric single (K042843) Submitter: Mercury Medical * Mercury medical disposable CPR bag (K91 1622) * Mercury medical reusable CPR bag (K970756) (4) Device description Functioningz and scientific concerts A resuscitator is a device using positive pressure to inflate th…	Mercury Medical	1997	—

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?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
1 of the 7 ancestors has a recall of any class.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · BTM

2in 2025

2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTM

83in 2008

2007high 83 (2008)2026

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

Recalls per year · BTM

9in 2024

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

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

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 Revivator resuscitator is intended for pulmonary resuscitation.

The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs)

The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs)

The infant resuscitator isfor infants with a body weight up to 7 kg (15 lbs)

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/K094003 · printed Nov 6, 2026

Cite this page

510(k) Report. “K094003: Revivator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094003

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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