510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Finger Tourniquette

K853472510(k) TraditionalCleared Oct 10, 198551-day reviewClass I21 CFR 878.5900Recalls 1

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

Joseph B. Marogil · GAX Tourniquet, Nonpneumatic

Cleared on Oct 10, 1985 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Oct 10, 1985
Review
51 days
Class
Class I
Product code
GAX
Recalls
1
Predicates
0

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

FIG. 1 — Lineage of K853472Source: 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.

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

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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)

Recalls of this device

DateClassRecallRoot causeReason
Dec 28, 2020Class IIZ-0945-2021Device DesignA failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type…

No ancestor or descendant has a Class I recall.

How does its category compare?

All GAX devices

GAX Tourniquet, Nonpneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAX

FDA has decided no GAX device since 2007.

Median 510(k) review, days · GAX

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

Recalls per year · GAX

1in 2020

2015: 12020: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAX

3in 2025

2007: 22008: 32009: 22010: 42011: 92012: 32013: 32014: 42015: 32016: 22017: 22018: 102019: 42020: 72022: 32023: 22024: 42025: 3
2007high 10 (2018) · low 0 (2021)2025

MAUDE reports naming product code GAX, 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—03
20090—02
20100—04
20110—09
20120—03
20130—03
20140—04
20150—13
20160—02
20170—02
20180—010
20190—04
20200—17
20210—00
20220—03
20230—02
20240—04
20250—03
20260—0—

Recent decisions in GAX

The GAX category page

  • K931198UniquetIcat Systems · 1993
  • K881398TourniquetBarretta Products, Research and Development, Inc. · 1988
  • K881176Sterile Esmarch BandageSpectrum/Hydro-Med Products, Inc. · 1988
  • K875092Degania Silicone TourniquetDegania Silicone, Ltd. · 1988
  • K873928Universal TourniquetDryden Corp. · 1987

https://510kreport.com/device/K853472 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853472: Finger Tourniquette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853472

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