510(k) Report

510(k) · Cleared

Cleared

Jain Graft Assist

K904536510(k) TraditionalCleared Nov 29, 199056-day reviewClass I21 CFR 878.4800

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

Jain Surgical Equipment, Inc. · GCZ Retainer, Surgical

Cleared on Nov 29, 1990 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 29, 1990
Review
56 days
Class
Class I
Product code
GCZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K904536Source: 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 GCZ? 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 GCZ devices

GCZ Retainer, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCZ

FDA has decided no GCZ device since 2007.

Median 510(k) review, days · GCZ

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

Recalls per year · GCZ

No recall names GCZ since 2007.

Adverse event reports per year · GCZ

1in 2025

2009: 12014: 12015: 32016: 32017: 82018: 82024: 12025: 1
2007high 8 (2017) · low 0 (2007)2025

MAUDE reports naming product code GCZ, 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—00
20080—00
20090—01
20100—00
20110—00
20120—00
20130—00
20140—01
20150—03
20160—03
20170—08
20180—08
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—01
20260—0—

More from Jain Surgical Equipment, Inc.

5 FDA decisions under this applicant name. See the company

  • K913896Jain Blood ShieldJain Surgical Equipment, Inc. · 1992
  • K911077Jain Suture Package CounterJain Surgical Equipment, Inc. · 1991
  • K911076Jain Quick CountJain Surgical Equipment, Inc. · 1991
  • K905105Jain Suture/Vesiband OrganizerJain Surgical Equipment, Inc. · 1991

Recent decisions in GCZ

The GCZ category page

  • K893870Adams Breast Implant ProtectorAdept-Med Intl., Inc. · 1989
  • K870809Mcnealy-Glassman Viscera Retainer #3202/3204/3206Adept-Med Intl., Inc. · 19871 recall
  • K802806Visecera RetainerAdept-Med Intl., Inc. · 19811 recall
  • K801610Children's Hospital Pediatric RetractorEdward Weck, Inc. · 1980

https://510kreport.com/device/K904536 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904536: Jain Graft Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904536

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