Cleared Traditional

K061679 - WALLACE ARTIFICIAL INSEMINATION CATHETER (FDA 510(k) Clearance)

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

K061679 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
120d
Days
Class 2
Risk

K061679 is an FDA 510(k) clearance for the WALLACE ARTIFICIAL INSEMINATION CATHETER. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 120 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 Irvine Scientific Sales Co., Inc. devices

Submission Details

510(k) Number K061679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date October 13, 2006
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 160d · This submission: 120d
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 K061679.
FemVue® Controlled Saline-Air Device (FSA-300)
K253403 · Femasys, Inc. · Dec 2025
RELIEEV HSG Catheter (HSG7FA1)
K252260 · Li Medical Corporation , Ltd. · Nov 2025
FemVue MINI Saline-Air Device
K242002 · Femasys, Inc. · Nov 2024
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
K240364 · Li Medical Corporation , Ltd. · Oct 2024
FemChec Controlled Saline-Air Device (FCD-250)
K241693 · Femasys, Inc. · Sep 2024
Rejoni Intrauterine Catheter
K222798 · Rejoni, Inc. · Dec 2022