510(k) Report

510(k) · Cleared

Recalled · Class I · 2025

Manual Pulmonary Resusicitator

K953546510(k) TraditionalCleared Feb 29, 1996216-day reviewClass II21 CFR 868.5915Recalls 16 (2 Class I)

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

Medical Marketing Concepts · BTM Ventilator, Emergency, Manual (Resuscitator)

Cleared on Feb 29, 1996 after a 216-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has a Class I recall. It has been recalled 16 times, including 2 Class I recalls.

Decided
Feb 29, 1996
Review
216 days
Class
Class II
Product code
BTM
Recalls
16 (2 Class I)
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K953546Source: FDA 510(k) database · 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), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 1, 2025Class IZ-1814-2025Process controlAffected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation…
May 24, 2018Class IIZ-2148-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2156-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2154-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2158-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2147-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2149-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2150-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2145-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2153-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2155-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2152-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2146-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2151-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 24, 2018Class IIZ-2157-2018Mixed-up of materials/componentsThere is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
May 16, 2014Class IZ-1948-2014Process change controlThe pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I 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.

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)—

More from Medical Marketing Concepts

13 FDA decisions under this applicant name. See the company

  • K982215Manual Resuscitator with AceMedical Marketing Concepts · 19982 Class I recalls
  • K961867Peep ValveMedical Marketing Concepts · 1996
  • K961330Bagright Infant ResuscitatorMedical Marketing Concepts · 1996
  • K961329Bagright Child ResuscitatorMedical Marketing Concepts · 1996
  • K961332Bagright Resposable Infant ResuscitatorMedical Marketing Concepts · 1996

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/K953546 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953546: Manual Pulmonary Resusicitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953546

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026