Cleared Traditional

K133838 - STERILIZATION POUCH/ROLL MADE WITH TYVEK (FDA 510(k) Clearance)

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

K133838 · Sigma Medical Supplies Corp. · General Hospital
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Mar 2015
Decision
448d
Days
Class 2
Risk

K133838 is an FDA 510(k) clearance for the STERILIZATION POUCH/ROLL MADE WITH TYVEK. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Sigma Medical Supplies Corp. (Kaohsiung City, TW). The FDA issued a Cleared decision on March 11, 2015 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sigma Medical Supplies Corp. devices

Submission Details

510(k) Number K133838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date March 11, 2015
Days to Decision 448 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
320d slower than avg
Panel avg: 128d · This submission: 448d
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 319
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K133838.
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