Cleared Traditional

K123136 - GENESIS HEALTH RECORD SYSTEM, (GHRS)

K123136 is an FDA 510(k) clearance for GENESIS HEALTH RECORD SYSTEM, manufactured by Genesis Health Technologies. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K123136 · Genesis Health Technologies · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
153d
Days
Class 2
Risk

K123136 is an FDA 510(k) clearance for the GENESIS HEALTH RECORD SYSTEM, (GHRS). Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Genesis Health Technologies (Fairfield, US). The FDA issued a Cleared decision on March 7, 2013 after a review of 153 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Genesis Health Technologies devices

FDA 510(k) Submission Details - K123136

510(k) Number K123136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2012
Decision Date March 07, 2013
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 422
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K123136.
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
K122307 · Biocare Corporation · Apr 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · Abbott Laboratories · Apr 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp. · Mar 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · Roche Diagnostics · Feb 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · Lifescan, Inc. · Feb 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
K120708 · Cilag GmbH International · Feb 2013