Cleared Traditional

SOFTSEAL HSG CATHETER (K040238) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K040238.
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RELIEEV Uterine Manipulator Injector (CUMI 5.0)
K240364 · Li Medical Corporation , Ltd. · Oct 2024
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K241693 · Femasys, Inc. · Sep 2024
Rejoni Intrauterine Catheter
K222798 · Rejoni, Inc. · Dec 2022