510(k) Report

510(k) · Cleared

Cleared

Disposable Adhesive Face Mask

K950771510(k) TraditionalCleared Mar 10, 1995382-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

Advanced Warming Systems, Inc. · BSJ Mask, Gas, Anesthetic

Cleared on Mar 10, 1995 after a 382-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 10, 1995
Review
382 days
Class
Class I
Product code
BSJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950771 Disposable Adhesive Face MaskAdvanced Warming Systems, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK123176 Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013
  3. Descendant · 2 generations on · 1 of its ownK132729 Iso-Gard MaskTeleflexmedical, Inc. · 2014
  4. Descendant · 3 generations on · 0 of its ownK142138 Iso-Gard MaskTeleflexmedical, Inc. · 2014
  5. Descendant · cites it directly · 0 of its ownK071915 Cpap MaskArcimed Laboratories, LLC · 2008

Most influential descendants

Showing 4 of 4 · See all
  • K123176Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013 · cites it directly2descendants
  • K132729Iso-Gard MaskTeleflexmedical, Inc. · 2014 · 2 generations on1descendant
  • K142138Iso-Gard MaskTeleflexmedical, Inc. · 2014 · 3 generations on0descendants
  • K071915Cpap MaskArcimed Laboratories, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950771Disposable Adhesive Face MaskAdvanced Warming Systems, Inc.1995—
+1K123176Iso-Gard Clearair MaskTeleflexmedical, Inc.2013—
+2K132729Iso-Gard MaskTeleflexmedical, Inc.2014—
+3K142138Iso-Gard MaskTeleflexmedical, Inc.2014—
+1K071915Cpap MaskArcimed Laboratories, LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201310
201420
FIG. 1 — Lineage of K950771, 1995–2014Source: 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), 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
Get a 510(k) Report

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? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123176Iso-Gard Clearair MaskTeleflexmedical, Inc.20132
K071915Cpap MaskArcimed Laboratories, LLC20080

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, K123176 (Teleflexmedical, Inc., 2013) has gone furthest, with 2 descendants 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 Advanced Warming Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K953269Safecircuit Manifold/Pulmonary UnitAdvanced Warming Systems, Inc. · 1996
  • K913016WarmtouchAdvanced Warming Systems, Inc. · 1991

Recent decisions in BSJ

The BSJ category page

  • K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc. · 2017
  • K953107Anesthesia/Respiratory Face MaskMedical Marketing Concepts · 1995
  • 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

https://510kreport.com/device/K950771 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950771: Disposable Adhesive 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/K950771

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026