Cleared Traditional

K032835 - H/S CATHETER SET (FDA 510(k) Clearance)

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

K032835 · Catheter Research, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
91d
Days
Class 2
Risk

K032835 is an FDA 510(k) clearance for the H/S CATHETER SET. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 11, 2003 after a review of 91 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 Catheter Research, Inc. devices

Submission Details

510(k) Number K032835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date December 11, 2003
Days to Decision 91 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
69d faster than avg
Panel avg: 160d · This submission: 91d
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 K032835.
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