Cleared Traditional

MEDLINE STERISET STERILIZATION CONTAINER (K010825) - FDA 510(k) Clearance

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

K010825 · Medline · General Hospital
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May 2001
Decision
50d
Days
Class 2
Risk

K010825 is an FDA 510(k) clearance for the MEDLINE STERISET STERILIZATION CONTAINER. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medline (Mundelein, US). The FDA issued a Cleared decision on May 8, 2001 after a review of 50 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 Medline devices

Submission Details

510(k) Number K010825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2001
Decision Date May 08, 2001
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 84
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K010825.
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
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992