Cleared Traditional

K030429 - STERRAD 200 STERILIZER

K030429 is an FDA 510(k) clearance for STERRAD 200 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 189-day FDA review.

K030429 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
189d
Days
Class 2
Risk

K030429 is an FDA 510(k) clearance for the STERRAD 200 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 August 18, 2003 after a review of 189 days - an extended review cycle.

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. Standard predicate reliance. 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 - K030429

510(k) Number K030429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2003
Decision Date August 18, 2003
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 K030429.
STERRAD 100NX STERILIZER
K071385 · Advanced Sterilization Products · Nov 2007
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
K062297 · STERIS Corporation · Oct 2007
STERRAD NX STERILIZER
K042116 · Advanced Sterilization Products · Apr 2005
STERRAD 100S STERILIZER
K991999 · Advanced Sterilization Products · Jun 2000
STERRAD 50 STERILIZER
K981625 · Advanced Sterilization Products · Jan 1999
MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE
K924380 · Mdt Corp., Inc. · Feb 1994