Cleared Traditional

K080538 - IDEAL LIFE POD (MODEL ILP 0001)

K080538 is the FDA 510(k) clearance for IDEAL LIFE POD (MODEL ILP 0001) by Ideal Life, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K080538 · Ideal Life, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
128d
Days
Class 2
Risk

K080538 is an FDA 510(k) clearance for the IDEAL LIFE POD (MODEL ILP 0001). Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ideal Life, Inc. (Fairfax, US). The FDA issued a Cleared decision on July 3, 2008 after a review of 128 days - within the typical 510(k) review window.

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 Ideal Life, Inc. devices

Submission Details

510(k) Number K080538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2008
Decision Date July 03, 2008
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K080538.
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
K081957 · Taidoc Technology Corporation · Aug 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
K073030 · Andon Health Co, Ltd. · Jul 2008
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K081389 · Roche Diagnostics · Jul 2008
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
K080283 · Taidoc Technology Corporation · Jun 2008
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
K081144 · Taidoc Technology Corporation · Jun 2008
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K080014 · Taidoc Technology Corporation · Jun 2008