Cleared Traditional

K053137 - ENDOTOOL DRUG DOSE CALCULATOR

K053137 is an FDA 510(k) clearance for ENDOTOOL DRUG DOSE CALCULATOR, manufactured by MD Scientific, LLC. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K053137 · MD Scientific, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K053137

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
Combination Product No
PCCP Authorized No
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.

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 General Hospital devices follow this clearance model.

Regulatory Peers - NDC Calculator, Drug Dose

All 55
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K053137.
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K071713 · Medical Decisions Network · Oct 2007
GLUCOMMANDER PLUS
K061110 · Collaborativemed, LLC · Jun 2006
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529 · Roche Diagnostics Corp. · Apr 2005
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
K011571 · The RX Files Corp. · Aug 2001
K053137 · ENDOTOOL DRUG DOSE CALCULATOR
Download PDF FDA Summary MD Scientific, LLC