510(k) Report

510(k) · Cleared

Cleared

Fraser Sweatman's Double Mask

K761140510(k) TraditionalCleared Dec 9, 197613-day reviewClass II21 CFR 868.5430

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

Fraser Sweatman, Inc. · CBN Apparatus, Gas-Scavenging

Cleared on Dec 9, 1976 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 9, 1976
Review
13 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared19801990200020102020
  1. This deviceK761140 Fraser Sweatman's Double MaskFraser Sweatman, Inc. · 1976
  2. Descendant · cites it directly · 0 of its ownK981754 Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K761140Fraser Sweatman's Double MaskFraser Sweatman, Inc.1976—
+1K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K761140, 1976–1998Source: 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 CBN? 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 CBN device

  1. #1 K223452 Nitronox Scavenger Plusscore 5.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc.19980

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, K981754 (Porter Instrument Co., Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CBN devices

CBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBN

1in 2023

2007: 12008: 12010: 12011: 12013: 12014: 22017: 12020: 12023: 1
2007high 2 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBN

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

Recalls per year · CBN

No recall names CBN since 2007.

Adverse event reports per year · CBN

1in 2025

2012: 12015: 12020: 22025: 1
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code CBN, 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
20071—00
20081—00
20090—00
20101—00
20111—00
20120—01
20131—00
20142—00
20150—01
20160—00
20171—00
20180—00
20190—00
20201—02
20210—00
20220—00
20231—00
20240—00
20250—01
20260—0—

More from Fraser Sweatman, Inc.

6 FDA decisions under this applicant name. See the company

  • K771299Emergency Oxygen ResuscitatorFraser Sweatman, Inc. · 1977
  • K770911Medishield Jordon Lifting FrameFraser Sweatman, Inc. · 1977
  • K770910Medishield Cervical CollarFraser Sweatman, Inc. · 1977
  • K760766Pre-Set 50/50 Nitrous Oxide/Oxygen MixerFraser Sweatman, Inc. · 1976
  • K760076Absorber, Anesthesia Circle Sys, CO2Fraser Sweatman, Inc. · 1976

Recent decisions in CBN

The CBN category page

  • K223452Nitronox Scavenger PlusParker Hannifin Corporation · 2023
  • K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc. · 2020
  • K160950MiniscavSedation Systems, LLC · 20171 recall
  • K142138Iso-Gard MaskTeleflexmedical, Inc. · 2014
  • K132729Iso-Gard MaskTeleflexmedical, Inc. · 2014

https://510kreport.com/device/K761140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K761140: Fraser Sweatman's Double Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K761140

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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