Cleared Traditional

K171823 - U&U Indicator tape and strip

K171823 is the FDA 510(k) clearance for U&U Indicator tape and strip by U&U Medical Technology Co, Ltd.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K171823 · U&U Medical Technology Co, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all U&U Medical Technology Co, Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 129d · 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 114
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K171823.
Celerity HP Chemical Indicator (CI)
K183295 · Steris Corporations · Jan 2019
CelerityTM 10 STEAM Chemical Indicator
K182724 · STERIS Corporation · Dec 2018
VERIFY Chemical Indicator for S40 Sterilant
K173428 · STERIS Corporation · Mar 2018
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
K172746 · STERIS Corporation · Feb 2018
VERIFY VH2O2 Indicator Tape
K172753 · STERIS Corporation · Feb 2018
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472 · STERIS Corporation · Nov 2017