510(k) Report

510(k) · Cleared

Cleared

Universal Tourniquet

K873928510(k) TraditionalCleared Oct 23, 198728-day reviewClass I21 CFR 878.5900

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

Dryden Corp. · GAX Tourniquet, Nonpneumatic

Cleared on Oct 23, 1987 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 23, 1987
Review
28 days
Class
Class I
Product code
GAX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K873928Source: 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.

  • Candidate predicates for a device like this, rankedin the report
  • 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 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—

More from Dryden Corp.

21 FDA decisions under this applicant name. See the company

  • K880923Patient Ventilator IsolatorDryden Corp. · 1988
  • K880769Breathing Circuit W/Heated WireDryden Corp. · 1988
  • K882285Nonrebreathing CircuitDryden Corp. · 1988
  • K873927Reuseable Breathing TubesDryden Corp. · 1987
  • K870859Bag-Tail Bleed ValveDryden Corp. · 1987

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
  • K872003KinderwrapThe Kinder Co. · 1987

https://510kreport.com/device/K873928 · printed Nov 4, 2026

Cite this page

510(k) Report. “K873928: Universal Tourniquet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873928

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