Cleared Traditional

K040238 - SOFTSEAL HSG CATHETER

K040238 is an FDA 510(k) clearance for SOFTSEAL HSG CATHETER, manufactured by Modern Medical Equipment Mfg., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K040238 · Modern Medical Equipment Mfg., Ltd. · Obstetrics & Gynecology device
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Jun 2004
Decision
148d
Days
Class 2
Risk

K040238 is an FDA 510(k) clearance for the SOFTSEAL HSG CATHETER. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Modern Medical Equipment Mfg., Ltd. (Richmond, US). The FDA issued a Cleared decision on June 22, 2004 after a review of 148 days - within the typical 510(k) review window.

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: 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 Modern Medical Equipment Mfg., Ltd. devices

FDA 510(k) Submission Details - K040238

510(k) Number K040238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date June 22, 2004
Days to Decision 148 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
12d faster than avg
Panel avg: 160d · This submission: 148d
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 44
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K040238.
SALINE/ CONTRAST MEDIA INFUSION CATHETER
K063611 · Utah Medical Products, Inc. · May 2007
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679 · Irvine Scientific Sales Co., Inc. · Oct 2006
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc. · Oct 2004
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