Cleared Traditional

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K233777) - FDA 510(k) Clearance

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

K233777 · Primed Medical Products, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2024
Decision
182d
Days
Class 2
Risk

K233777 is an FDA 510(k) clearance for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on May 24, 2024 after a review of 182 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 Primed Medical Products, Inc. devices

Submission Details

510(k) Number K233777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2023
Decision Date May 24, 2024
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K233777.
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · O&M Halyard, Inc. · Aug 2024
Medicom Sterilization Wrap
K240862 · Medicom Group, Inc. · Jun 2024
Steriking® Pouch for Robotic Instruments
K232625 · Wipak OY · Jun 2024
Dukal SMS Sterilization Wrap
K233262 · Dukal, LLC · Mar 2024
Reliance® Fusion Sterilization Wraps
K230137 · Ahlstrom-Munksjo Nonwovens, LLC · Dec 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231996 · Wipak OY · Sep 2023