Cleared Traditional

K240438 - CDB Hospital Sterilization Wrap (70 gsm)

Also marketed or referenced as:
CDB Hospital ® Sterilization Wrap (44 gsm)

K240438 is an FDA 510(k) clearance for CDB Hospital Sterilization Wrap (70 gsm), manufactured by Comercializadora Brever. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K240438 · Comercializadora Brever · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
264d
Days
Class 2
Risk

K240438 is an FDA 510(k) clearance for the CDB Hospital ® Sterilization Wrap (70 gsm). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Comercializadora Brever (Leon, MX). The FDA issued a Cleared decision on November 4, 2024 after a review of 264 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 Comercializadora Brever devices

FDA 510(k) Submission Details - K240438

510(k) Number K240438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2024
Decision Date November 04, 2024
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
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 147
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K240438.
Sterilization Package/Reel
K241565 · Anqing Clean Dental Instrument Technology Co., Ltd. · Feb 2025
Sterilization Pouches and Reels
K242898 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Feb 2025
Medicom Sterilization Pouch and Reel
K243431 · Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. · Feb 2025
Safe Secure Sterilization Pouches and Rolls
K242839 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Oct 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K242208 · Primed Medical Products, Inc. · Oct 2024
Perpak™ Sterilization Tyvek Pouch
K241123 · Km Corp. · Sep 2024