Cleared Traditional

K212911 - Konig Mogen Clamp (FDA 510(k) Clearance)

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

K212911 · Medline Industries, Inc. · Obstetrics & Gynecology device
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Nov 2022
Decision
431d
Days
Class 2
Risk

K212911 is an FDA 510(k) clearance for the Konig Mogen Clamp. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on November 18, 2022 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K212911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2021
Decision Date November 18, 2022
Days to Decision 431 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 160d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFX Clamp, Circumcision
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.