510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864121Substantially Equivalent

Pharmacokinetics Software System (Pps)

Pharmatrol, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864121 is the FDA 510(k) clearance record for PHARMACOKINETICS SOFTWARE SYSTEM (PPS), a class II device, cleared for Pharmatrol, Inc. on under FDA product code NDC (Calculator, Drug Dose). FDA records list one 510(k) clearance for Pharmatrol, Inc. As of , FDA records show no recalls naming K864121.

Clearance record

Decision date
Received
(50 days to decision)
Product code
NDC Calculator, Drug Dose
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Pharmatrol, Inc. 1801 E. 12th St., Cleveland OH
Third party review
No

Clearances, product code NDC

Trailing 12 months
5 clearances under product code NDC in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NDC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20261