Cleared Traditional

K915682 - STERRAD 100 STERILIZATION SYSTEM

K915682 is the FDA 510(k) clearance for STERRAD 100 STERILIZATION SYSTEM by Johnson & Johnson Medical, Inc.. It is a Class 2 General Hospital device (product code FLF) cleared through the Traditional 510(k) pathway after a 652-day FDA review.

K915682 · Johnson & Johnson Medical, Inc. · General Hospital
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Oct 1993
Decision
652d
Days
Class 2
Risk

K915682 is an FDA 510(k) clearance for the STERRAD 100 STERILIZATION SYSTEM. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 652 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K915682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date October 01, 1993
Days to Decision 652 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
523d slower than avg
Panel avg: 129d · This submission: 652d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLF Sterilizer, Ethylene-oxide Gas
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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 - FLF Sterilizer, Ethylene-oxide Gas

All 8
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K915682.
STERRAD 50 & STERRAD 100S STERILIZERS
K023290 · Advanced Sterilization Products · Apr 2003
STERI-VAC GAS STERILIZER MODEL 8XL
K941748 · 3M Health Care, Ltd. · Dec 1994
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · American Sterilizer Co. · Feb 1994
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · 3M Company · Jul 1990
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · Sybron Corp. · Apr 1982
STERI-VAC #400C GAS STERILIZER
K812867 · 3M Company · Nov 1981