Cleared Traditional

K960239 - CPR D & C TRAY

K960239 is an FDA 510(k) clearance for CPR D & C TRAY, manufactured by Custom Pack Reliability. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K960239 · Custom Pack Reliability · Obstetrics & Gynecology device
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May 1996
Decision
128d
Days
Class 2
Risk

K960239 is an FDA 510(k) clearance for the CPR D & C TRAY. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K960239

510(k) Number K960239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date May 23, 1996
Days to Decision 128 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
33d faster than avg
Panel avg: 161d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHK Device Classification - Class 2, Special Controls

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
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 - HHK Curette, Suction, Endometrial (and Accessories)

All 29
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K960239.
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
K991895 · Ri Mos. S.R.L. · Aug 1999
ENDOMETRIAL SAMPLER
K990387 · U.A. Medical Products, Inc. · Apr 1999
SELECTCELLS(TM) MINI
K974819 · Select Medical Systems, Inc. · Mar 1998
SELECTCELLS STANDARD
K954097 · Select Medical Systems, Inc. · Nov 1995
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
K952652 · Medscand (Usa), Inc. · Sep 1995
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · Cabot Medical Corp. · Feb 1988
K960239 · CPR D & C TRAY
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