Cleared Traditional

Sterilization Trays

K251756 · Paragon Implant Mfg., LLC · General Hospital

Nov 2025

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K251756 is an FDA 510(k) clearance for the Sterilization Trays, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Paragon Implant Mfg., LLC (Calabasas, US). The FDA issued a Cleared decision on November 14, 2025, 158 days after receiving the submission on June 9, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K251756 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2025
Decision Date	November 14, 2025
Days to Decision	158 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850