PHYClass II

Sparse Sample Pk Profile And Dosing Software

21 CFR 868.1890 / Anesthesiology

PHY is the FDA product code for Sparse Sample Pk Profile And Dosing Software, a class II device type, regulated under 21 CFR 868.1890. FDA's definition for this code reads: "To estimate PK profile and dosing calculation". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PHY
Device name: Sparse Sample Pk Profile And Dosing Software
FDA definition: To estimate PK profile and dosing calculation.
Regulation: 21 CFR 868.1890
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Takeda Pharmaceuticals U.S.A., Inc.

Recent clearances

Product code PHY

FDA records hold no clearances under product code PHY.

Recent recalls

Product code PHY

FDA records show no recalls under product code PHY.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)