Cleared Traditional

METAPAK MULTI-PURPOSE INSTRUMENT TRAY (K993535) - FDA 510(k) Clearance

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

K993535 · Riley Medical, Inc. · General Hospital
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Dec 2001
Decision
780d
Days
Class 2
Risk

K993535 is an FDA 510(k) clearance for the METAPAK MULTI-PURPOSE INSTRUMENT TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Riley Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 780 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 Riley Medical, Inc. devices

Submission Details

510(k) Number K993535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1999
Decision Date December 07, 2001
Days to Decision 780 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
651d slower than avg
Panel avg: 129d · This submission: 780d
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 88
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K993535.
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
K071087 · STERIS Corporation · Oct 2007
AESCULAP STERILCONTAINER SYSTEM
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REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · GE Medical Systems · Feb 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996