Cleared Traditional

K014167 - LIBERTY BLOOD GLUCOSE MONITORING SYSTEM

K014167 is an FDA 510(k) clearance for LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Polymedica Pharmaceuticals, U.S.A., Inc.]. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K014167 · Polymedica Pharmaceuticals, U.S.A., Inc.] · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
62d
Days
Class 2
Risk

K014167 is an FDA 510(k) clearance for the LIBERTY BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Polymedica Pharmaceuticals, U.S.A., Inc.] (Woburn, US). The FDA issued a Cleared decision on February 19, 2002 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K014167

510(k) Number K014167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2001
Decision Date February 19, 2002
Days to Decision 62 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
27d faster than avg
Panel avg: 89d · This submission: 62d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K014167.
GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
K020210 · Bayer Group Diagnostics · Apr 2002
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
K020208 · Bayer Group Diagnostics · Apr 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · Abbott Laboratories · Feb 2002
BIOSCANNER PLUS
K014099 · Polymer Technology Systems, Inc. · Dec 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · Abbott Diabetes Care, Inc. · Dec 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · Roche Diagnostics Corp. · Dec 2001
K014167 · LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Polymedica Pharmaceut…