Cleared Traditional

K213907 - CareGUARD Sterilization Wrap

K213907 is an FDA 510(k) clearance for CareGUARD Sterilization Wrap, manufactured by Care Essentials Pty, Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K213907 · Care Essentials Pty, Ltd. · General Hospital
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Mar 2022
Decision
90d
Days
Class 2
Risk

K213907 is an FDA 510(k) clearance for the CareGUARD Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Care Essentials Pty, Ltd. (North Geelong, AU). The FDA issued a Cleared decision on March 14, 2022 after a review of 90 days - within the typical 510(k) review window.

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 Care Essentials Pty, Ltd. devices

FDA 510(k) Submission Details - K213907

510(k) Number K213907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2021
Decision Date March 14, 2022
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

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 162
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K213907.
Solidence Multipockets
K191131 · Solidence Surgical Corporation · Aug 2022
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K214007 · Owens & Minor (O&M) Halyard, Inc. · Jul 2022
Steriking Packaging for Medical Devices
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Sterilization Wraps
K220133 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Mar 2022
Steiking Packaging for Medical Devices
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K212338 · Sterileright Packaging Mfg., Inc. · Nov 2021