Cleared Traditional

K051101 - VERIFY FLASH INTEGRATOR

K051101 is an FDA 510(k) clearance for VERIFY FLASH INTEGRATOR, 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 221-day FDA review.

K051101 · Albert Browne , Ltd. · General Hospital
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Dec 2005
Decision
221d
Days
Class 2
Risk

K051101 is an FDA 510(k) clearance for the VERIFY FLASH INTEGRATOR. 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 December 6, 2005 after a review of 221 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 Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K051101

510(k) Number K051101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date December 06, 2005
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 K051101.
VERIFY DRY HEAT LABEL
K053479 · Albert Browne , Ltd. · Jul 2006
VERIFY 3-10 MIN FLASH INTEGRATOR
K060066 · Albert Browne , Ltd. · Mar 2006
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
K060103 · Albert Browne , Ltd. · Mar 2006
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388 · Serim Research Corp. · Dec 2005
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · Propper Mfg. Co., Inc. · Aug 2004