Cleared Traditional

K171823 - U&U Indicator tape and strip (FDA 510(k) Clearance)

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

K171823 · U&U Medical Technology Co, Ltd. · General Hospital
Feb 2018
Decision
248d
Days
Class 2
Risk

K171823 is an FDA 510(k) clearance for the U&U Indicator tape and strip. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by U&U Medical Technology Co, Ltd. (Changzhou, CN). The FDA issued a Cleared decision on February 22, 2018 after a review of 248 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.

Submission Details

510(k) Number K171823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2017
Decision Date February 22, 2018
Days to Decision 248 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 169d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K171823.
LF Process Indicator Tape for Steam Sterilization
K260181 · Intertape Polymer Group · Feb 2026
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Dec 2025
DISINTEK™ PA Test Strips
K251035 · Serim Research · Jun 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · STERIS Corporation · May 2025
VERIFY STEAM Integrating Indicator
K243876 · STERIS Corporation · Apr 2025
Chemical Indicator for enspire CLCSPS (LCC015)
K243475 · STERIS Corporation · Dec 2024