Cleared Traditional

TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE (K011571) - FDA 510(k) Clearance

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

K011571 · The RX Files Corp. · General Hospital
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Aug 2001
Decision
80d
Days
Class 2
Risk

K011571 is an FDA 510(k) clearance for the TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by The RX Files Corp. (Crofton, US). The FDA issued a Cleared decision on August 9, 2001 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The RX Files Corp. devices

Submission Details

510(k) Number K011571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date August 09, 2001
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
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.