Cleared Traditional

FLASHPAK (K113776) - FDA 510(k) Clearance

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

K113776 · Symmetry Medical · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
230d
Days
Class 2
Risk

K113776 is an FDA 510(k) clearance for the FLASHPAK. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Symmetry Medical (New Bedford, US). The FDA issued a Cleared decision on August 8, 2012 after a review of 230 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 Symmetry Medical devices

Submission Details

510(k) Number K113776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date August 08, 2012
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
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 321
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K113776.
Dukal Crepe Paper Sterilization Wrap
K252823 · Dukal, LLC · May 2026
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Sterilization Pouch/Roll
K251347 · Sterivic Medical Co., Ltd. · Jan 2026
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K251177 · Guangdong Maidi Medical Co., Ltd. · Dec 2025
Chex-All Sterilization Pouches and Tubes
K250306 · Propper Manufacturing Co., Inc. · Oct 2025
Sterilization Pouch and Roll
K243179 · Yichang Xinxin Paper Products Co., Ltd. · Jun 2025