Cleared Traditional

ENDOTOOL DRUG DOSE CALCULATOR (K053137) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053137 · MD Scientific, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
217d
Days
Class 2
Risk

K053137 is an FDA 510(k) clearance for the ENDOTOOL DRUG DOSE CALCULATOR. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by MD Scientific, LLC (Charlotte, US). The FDA issued a Cleared decision on June 14, 2006 after a review of 217 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K053137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2005
Decision Date June 14, 2006
Days to Decision 217 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 129d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 General Hospital devices follow this clearance model.