Cleared Traditional

K240637 - RIGHTEST Blood Glucose Monitoring System Max Tel

K240637 is an FDA 510(k) clearance for RIGHTEST Blood Glucose Monitoring Syste..., manufactured by Bionime Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K240637 · Bionime Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
243d
Days
Class 2
Risk

K240637 is an FDA 510(k) clearance for the RIGHTEST Blood Glucose Monitoring System Max Tel. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bionime Corporation (Taichung City, TW). The FDA issued a Cleared decision on November 4, 2024 after a review of 243 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 Bionime Corporation devices

FDA 510(k) Submission Details - K240637

510(k) Number K240637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2024
Decision Date November 04, 2024
Days to Decision 243 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
155d slower than avg
Panel avg: 88d · This submission: 243d
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 Consultant

Dynamic Biotech, Inc. Dba. Ivdd Regulatory Consultant
Feng-Yu Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 420
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