Cleared Traditional

K234084 - STERRAD Chemical Indicator (CI) Strip (...

Also marketed or referenced as:
STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL) STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count) STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count) STERRAD VELOCITY™ Reader (43220) ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)

K234084 is an FDA 510(k) clearance for STERRAD Chemical Indicator (CI) Strip (..., manufactured by Advanced Sterilization Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K234084 · Advanced Sterilization Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
196d
Days
Class 2
Risk

K234084 is an FDA 510(k) clearance for the STERRAD™ Chemical Indicator (CI) Strip (14100). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Advanced Sterilization Products, Inc. (Irvin, US). The FDA issued a Cleared decision on July 5, 2024 after a review of 196 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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, Inc. devices

FDA 510(k) Submission Details - K234084

510(k) Number K234084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date July 05, 2024
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - JOJ Indicator, Physical/chemical Sterilization Process

All 153
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K234084.
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