Cleared Traditional

K896960 - INTRAUTERINE INSEMINATION CATHETERS

K896960 is an FDA 510(k) clearance for INTRAUTERINE INSEMINATION CATHETERS, manufactured by C.R. Bard, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K896960 · C.R. Bard, Inc. · Obstetrics & Gynecology device
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Jun 1990
Decision
194d
Days
Class 2
Risk

K896960 is an FDA 510(k) clearance for the INTRAUTERINE INSEMINATION CATHETERS. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 194 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K896960

510(k) Number K896960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1989
Decision Date June 26, 1990
Days to Decision 194 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 160d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDR Device Classification - Class 2, Special Controls

Product Code HDR Cap, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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 - HDR Cap, Cervical

All 14
Devices cleared under the same product code (HDR) and FDA review panel - the closest regulatory comparables to K896960.
COOK INSEMINATION CUP
K950714 · Cook Urological, Inc. · May 1995
MINISPACE(TM) IUI CATHETER
K902171 · Pharmacia, Inc. · Oct 1990
COAXIAL CATHETER SET
K902694 · Cook Ob/Gyn · Aug 1990
SPERM SELECT SYSTEM
K900308 · Pharmacia, Inc. · Apr 1990
DGH A-SAN PROBE HOLDER
K900162 · Jedmed Instrument Co. · Feb 1990
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301 · Cook Ob/Gyn · Mar 1989