Cleared Traditional

K242839 - Safe Secure Sterilization Pouches and Rolls (FDA 510(k) Clearance)

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

K242839 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
27d
Days
Class 2
Risk

K242839 is an FDA 510(k) clearance for the Safe Secure Sterilization Pouches and Rolls. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2024 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. devices

Submission Details

510(k) Number K242839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2024
Decision Date October 16, 2024
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRG Wrap, Sterilization

All 319
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K242839.
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K250321 · George Courey, Inc. · Jun 2025
Self Sealing Sterilization Pouches
K243721 · Wellmed Dental Medical Supply Co., Ltd. · Apr 2025