Cleared Traditional

K935820 - KOLSTER METHODS

K935820 is an FDA 510(k) clearance for KOLSTER METHODS, manufactured by Kolster Methods. The device is a Class 2 Obstetrics & Gynecology device with product code HGH cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K935820 · Kolster Methods · Obstetrics & Gynecology device
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Jul 1994
Decision
228d
Days
Class 2
Risk

K935820 is an FDA 510(k) clearance for the KOLSTER METHODS. Classified as Cannula, Suction, Uterine (product code HGH), Class II - Special Controls.

Submitted by Kolster Methods (Anaheim, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 228 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - 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 Kolster Methods devices

FDA 510(k) Submission Details - K935820

510(k) Number K935820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date July 19, 1994
Days to Decision 228 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
68d slower than avg
Panel avg: 160d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGH Device Classification - Class 2, Special Controls

Product Code HGH Cannula, Suction, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
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 - HGH Cannula, Suction, Uterine

Devices cleared under the same product code (HGH) and FDA review panel - the closest regulatory comparables to K935820.
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K840285 · Imex Medical Systems, Inc. · May 1984