Cleared Traditional

SteriTite Container System with MediTray Products (K212711) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212711 · Case Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
246d
Days
Class 2
Risk

K212711 is an FDA 510(k) clearance for the SteriTite Container System with MediTray Products. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Case Medical, Inc. (Bloomfield, US). The FDA issued a Cleared decision on April 29, 2022 after a review of 246 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Case Medical, Inc. devices

Submission Details

510(k) Number K212711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2021
Decision Date April 29, 2022
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 139
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K212711.
S.I.N. Instrument Kits
K222005 · S.I.N. ? Sistema DE Implante Nacional S.A. · Sep 2022
SteriCUBE® Multiple Tray Sterilization Systems
K222328 · Stericube, LLC · Sep 2022
Surgical and Prosthetic Trays
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Neodent Implant System-Helix NGM Compact Surgical Kit Cases
K214051 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Apr 2022
Surgical Trays
K212281 · Dentsply Sirona, Inc. · Mar 2022
Southern Implants Instrument Trays
K210923 · Southern Implants (Pty), Ltd. · Mar 2022