510(k) Report

510(k) · Cleared

Cleared

Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer

K760766510(k) TraditionalCleared Oct 8, 19764-day reviewClass II21 CFR 868.5330

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

Fraser Sweatman, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation

Cleared on Oct 8, 1976 after a 4-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
Oct 8, 1976
Review
4 days
Class
Class II
Product code
BZR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2021: 1 descendant cleared19801990200020102020
  1. This deviceK760766 Pre-Set 50/50 Nitrous Oxide/Oxygen MixerFraser Sweatman, Inc. · 1976
  2. Descendant · cites it directly · 0 of its ownK202480 Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K760766Pre-Set 50/50 Nitrous Oxide/Oxygen MixerFraser Sweatman, Inc.1976—
+1K202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K760766, 1976–2021Source: 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 BZR? 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 BZR device

  1. #1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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
K202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin20210

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, K202480 (Parker Hannifin, 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BZR devices

BZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZR

1in 2025

2008: 12009: 12010: 12011: 22012: 22015: 12016: 12018: 12021: 12023: 42024: 12025: 1
2007high 4 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZR

203in 2023

2023: 203 days median
2007high 203 (2023)2026

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

Recalls per year · BZR

No recall names BZR since 2007.

Adverse event reports per year · BZR

13in 2025

2007: 152008: 202009: 42010: 222011: 112012: 272013: 182014: 112015: 392016: 302017: 222018: 242019: 262020: 152021: 332022: 152023: 192024: 182025: 13
2007high 39 (2015) · low 4 (2009)2025

MAUDE reports naming product code BZR, 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—015
20081—020
20091—04
20101—022
20112—011
20122—027
20130—018
20140—011
20151—039
20161—030
20170—022
20181—024
20190—026
20200—015
20211—033
20220—015
20234203019
20241—018
20251—013
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
  • K761140Fraser Sweatman's Double MaskFraser Sweatman, Inc. · 1976
  • K760076Absorber, Anesthesia Circle Sys, CO2Fraser Sweatman, Inc. · 1976

Recent decisions in BZR

The BZR category page

  • K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd. · 2025
  • K241465Midas Flowmeter; eAVSParker Hannifin Corporation · 2024
  • K231895Maxtec MaxBlend2+pMaxtec, LLC · 2023
  • K230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KG · 2023
  • K222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG · 2023

https://510kreport.com/device/K760766 · printed Nov 4, 2026

Cite this page

510(k) Report. “K760766: Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K760766

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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