Cleared Traditional

K974286 - CIRCUMCISION TRAY, CAT. NO. 70340

K974286 is an FDA 510(k) clearance for CIRCUMCISION TRAY, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K974286 · Trinity Laboratories, Inc. · Obstetrics & Gynecology device
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Dec 1997
Decision
28d
Days
Class 2
Risk

K974286 is an FDA 510(k) clearance for the CIRCUMCISION TRAY, CAT. NO. 70340. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on December 12, 1997 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K974286

510(k) Number K974286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1997
Decision Date December 12, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 161d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFX Device Classification - Class 2, Special Controls

Product Code HFX Clamp, Circumcision
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFX Clamp, Circumcision

All 23
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K974286.
SMART KLAMP VARIOUS BY SIZE
K032091 · Emergogroup, Inc. · Mar 2004
T.S. MEDICAL CIRCUMCISION CLAMP
K033403 · T.S. Medical · Jan 2004
KILEJIAN CIRCUMCISOR
K010867 · Iris Surgical, LLC · May 2001
MEDLINE CIRCUMCISION TRAY
K970282 · Medline · Mar 1997
CIRCUMCISION TRAY
K935697 · Cush Medical Products · May 1994
MOGAN CIRCUMCISION CLAMP
K926471 · Thomasville Medical Assoc. · Feb 1994