Konig Bell Circumcision Clamp (K251687): 510(k) cleared Feb 25, 2026

Konig Bell Circumcision Clamp

Medline Industries, LP · Feb 25, 2026 · K251687

FDA cleared the Konig Bell Circumcision Clamp from Medline Industries, LP on Feb 25, 2026 under K251687, a traditional 510(k). The device falls under product code HFX, Clamp, Circumcision, regulated at 21 CFR 884.4530 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 2, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medline Industries, LP has 5 other decisions in the tracker over the last 12 months: K253526 (NAMIC Dilator and Sheath), K254287 (Medline Reusable Blood Pressure Cuff), K253322 (Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)), K253070 (Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)).

Questions & Answers

What did FDA clear under K251687?

K251687 is the FDA 510(k) for Konig Bell Circumcision Clamp, submitted by Medline Industries, LP. FDA's decision date was Feb 25, 2026, under product code HFX (Clamp, Circumcision).

Who makes the Konig Bell Circumcision Clamp?

Medline Industries, LP, based in Northfiled, IL, is the applicant of record for K251687.

How long did the K251687 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Feb 25, 2026, 268 days later.

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