510(k) Report

510(k) · Cleared

Cleared

Anesthesia/Respiratory Face Mask

K953107510(k) TraditionalCleared Aug 15, 199543-day reviewClass I21 CFR 868.5550

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

Medical Marketing Concepts · BSJ Mask, Gas, Anesthetic

Cleared on Aug 15, 1995 after a 43-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 15, 1995
Review
43 days
Class
Class I
Product code
BSJ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953107 Anesthesia/Respiratory Face MaskMedical Marketing Concepts · 1995
  2. Descendant · cites it directly · 1 of its ownK163277 SuperNO2VA DeviceRevolutionary Medical Devices, Inc. · 2017
  3. Descendant · 2 generations on · 0 of its ownK173147 SuperNO2VA Et DeviceRevolutionary Medical Devices, Inc. · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc. · 2017 · cites it directly1descendant
  • K173147SuperNO2VA Et DeviceRevolutionary Medical Devices, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953107Anesthesia/Respiratory Face MaskMedical Marketing Concepts1995—
+1K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.2017—
+2K173147SuperNO2VA Et DeviceRevolutionary Medical Devices, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
FIG. 1 — Lineage of K953107, 1995–2018Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BSJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.20171

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?

  • Of its descendants, K163277 (Revolutionary Medical Devices, Inc., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All BSJ devices

BSJ Mask, Gas, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSJ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSJ

Too few BSJ 510(k)s in any year since 2007 to give a median.

Recalls per year · BSJ

1in 2011

2011: 1, 1 Class I
2007high 1 (2011) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSJ

2in 2025

2007: 22009: 22010: 12011: 12012: 52013: 42014: 122015: 12016: 42018: 62019: 112020: 12021: 112022: 112023: 52024: 42025: 2
2007high 12 (2014) · low 0 (2008)2025

MAUDE reports naming product code BSJ, 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
20070—02
20080—00
20090—02
20100—01
20110—1 (1)1
20120—05
20130—04
20140—012
20150—01
20160—04
20171—00
20180—06
20190—011
20200—01
20210—011
20220—011
20230—05
20240—04
20250—02
20260—0—

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
  • K961329Bagright Child ResuscitatorMedical Marketing Concepts · 1996
  • K961330Bagright Infant ResuscitatorMedical Marketing Concepts · 1996
  • K961882Resposable Infant ResuscitatorMedical Marketing Concepts · 1996

Recent decisions in BSJ

The BSJ category page

  • K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc. · 2017
  • K953295Anesthesia Face MaskMallinckrodt Medical · 1995
  • K952689Brigam Medical Disposable Anesthesia/Respiratory Face MaskOwens-Brigam Medical Co. · 1995
  • K951043Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskPromedic, Inc. · 1995
  • K950771Disposable Adhesive Face MaskAdvanced Warming Systems, Inc. · 1995

https://510kreport.com/device/K953107 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953107: Anesthesia/Respiratory Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953107

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