Cleared Traditional

K022503 - UTERINE INJECTOR

K022503 is an FDA 510(k) clearance for UTERINE INJECTOR, manufactured by Thomas Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K022503 · Thomas Medical, Inc. · Obstetrics & Gynecology device
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Oct 2002
Decision
88d
Days
Class 2
Risk

K022503 is an FDA 510(k) clearance for the UTERINE INJECTOR. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Thomas Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 88 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 Thomas Medical, Inc. devices

FDA 510(k) Submission Details - K022503

510(k) Number K022503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date October 25, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKF Device Classification - Class 2, Special Controls

Product Code LKF Cannula, Manipulator/injector, Uterine
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 - LKF Cannula, Manipulator/injector, Uterine

All 59
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K022503.
WALLACE ARTIFICIAL INSEMINATION CATHETER
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INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc. · Oct 2004
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
K023051 · Prosurg, Inc. · Dec 2002
SIB CATHETER, MODEL 61-7005
K021272 · Ackrad Laboratories · May 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
K020954 · Ackrad Laboratories · Apr 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · Ackrad Laboratories · Apr 2002