Cleared Traditional

K000418 - PDT DOSECALCULATOR, MODEL 80000

K000418 is an FDA 510(k) clearance for PDT DOSECALCULATOR, manufactured by Retinalabs.Com. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K000418 · Retinalabs.Com · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
259d
Days
Class 2
Risk

K000418 is an FDA 510(k) clearance for the PDT DOSECALCULATOR, MODEL 80000. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on October 24, 2000 after a review of 259 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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FDA 510(k) Submission Details - K000418

510(k) Number K000418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2000
Decision Date October 24, 2000
Days to Decision 259 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
130d slower than avg
Panel avg: 129d · This submission: 259d
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.