Cleared Traditional

K230813 - BlueStar and BlueStar Rx

K230813 is an FDA 510(k) clearance for BlueStar and BlueStar Rx, manufactured by Welldoc, Inc.. The device is a Class 2 Chemistry device with product code NDC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K230813 · Welldoc, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
126d
Days
Class 2
Risk

K230813 is an FDA 510(k) clearance for the BlueStar and BlueStar Rx. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on July 28, 2023 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 868.1890 - 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 Welldoc, Inc. devices

FDA 510(k) Submission Details - K230813

510(k) Number K230813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2023
Decision Date July 28, 2023
Days to Decision 126 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
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - NDC Calculator, Drug Dose

All 24
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