Cleared Traditional

K063285 - RELIANCE CI PROCESS INDICATOR

K063285 is an FDA 510(k) clearance for RELIANCE CI PROCESS INDICATOR, manufactured by Albert Browne , Ltd.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K063285 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
73d
Days
Class 2
Risk

K063285 is an FDA 510(k) clearance for the RELIANCE CI PROCESS INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Albert Browne , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K063285

510(k) Number K063285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2006
Decision Date January 12, 2007
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 193
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K063285.
VERIFY 275 DEGREE F. 3-10 INDICATOR
K071895 · STERIS Corporation · Nov 2007
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK
K070895 · STERIS Corporation · Sep 2007
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
K070461 · STERIS Corporation · Jul 2007
STEAMPLUS STEAM INTEGRATOR
K063799 · Spsmedical Supply Corp. · Jan 2007
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
K061738 · Albert Browne , Ltd. · Aug 2006
VERIFY DRY HEAT LABEL
K053479 · Albert Browne , Ltd. · Jul 2006