Cleared Traditional

K864121 - PHARMACOKINETICS SOFTWARE SYSTEM (PPS)

K864121 is an FDA 510(k) clearance for PHARMACOKINETICS SOFTWARE SYSTEM (PPS), manufactured by Pharmatrol, Inc.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K864121 · Pharmatrol, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
50d
Days
Class 2
Risk

K864121 is an FDA 510(k) clearance for the PHARMACOKINETICS SOFTWARE SYSTEM (PPS). Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Pharmatrol, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 50 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 Pharmatrol, Inc. devices

FDA 510(k) Submission Details - K864121

510(k) Number K864121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date December 10, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 51
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K864121.
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
PDT DOSECALCULATOR, MODEL 80000
K000418 · Retinalabs.Com · Oct 2000
ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · Abbott Laboratories · Jan 1986