Cleared Traditional

K991999 - STERRAD 100S STERILIZER

K991999 is an FDA 510(k) clearance for STERRAD 100S STERILIZER, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code MLR cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K991999 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
367d
Days
Class 2
Risk

K991999 is an FDA 510(k) clearance for the STERRAD 100S STERILIZER. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on June 15, 2000 after a review of 367 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Advanced Sterilization Products devices

FDA 510(k) Submission Details - K991999

510(k) Number K991999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date June 15, 2000
Days to Decision 367 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
238d slower than avg
Panel avg: 129d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLR Device Classification - Class 2, Special Controls

Product Code MLR Sterilizer, Chemical
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 - MLR Sterilizer, Chemical

All 45
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K991999.
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
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K030429 · Advanced Sterilization Products · Aug 2003
STERRAD 50 STERILIZER
K981625 · Advanced Sterilization Products · Jan 1999
MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE
K924380 · Mdt Corp., Inc. · Feb 1994