Cleared Traditional

K053479 - VERIFY DRY HEAT LABEL

K053479 is an FDA 510(k) clearance for VERIFY DRY HEAT LABEL, 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 216-day FDA review.

K053479 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
216d
Days
Class 2
Risk

K053479 is an FDA 510(k) clearance for the VERIFY DRY HEAT LABEL. 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 July 18, 2006 after a review of 216 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 - K053479

510(k) Number K053479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2005
Decision Date July 18, 2006
Days to Decision 216 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
87d slower than avg
Panel avg: 129d · This submission: 216d
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 K053479.
RELIANCE CI PROCESS INDICATOR
K063285 · Albert Browne , Ltd. · Jan 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 3-10 MIN FLASH INTEGRATOR
K060066 · Albert Browne , Ltd. · Mar 2006
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
K060103 · Albert Browne , Ltd. · Mar 2006
VERIFY FLASH INTEGRATOR
K051101 · Albert Browne , Ltd. · Dec 2005