510(k) Report

510(k) · Cleared

Cleared

Yoke Assembly Medical Gas

K935283510(k) TraditionalCleared Mar 11, 1994128-day reviewClass I21 CFR 868.6885

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

American Gage & Medical, Inc. · CAM Yoke Assembly, Medical Gas

Cleared on Mar 11, 1994 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 11, 1994
Review
128 days
Class
Class I
Product code
CAM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K935283Source: 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.

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  • Recall history across each candidate’s familyin the report
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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All CAM devices

CAM Yoke Assembly, Medical Gas: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAM

FDA has decided no CAM device since 2007.

Median 510(k) review, days · CAM

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

Recalls per year · CAM

No recall names CAM since 2007.

Adverse event reports per year · CAM

4in 2009

2007: 12008: 12009: 4
2007high 4 (2009) · low 0 (2010)2025

MAUDE reports naming product code CAM, 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—01
20080—01
20090—04
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in CAM

The CAM category page

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https://510kreport.com/device/K935283 · printed Nov 5, 2026

Cite this page

510(k) Report. “K935283: Yoke Assembly Medical Gas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935283

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