510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190487Substantially Equivalent

InPen Dose Calculator

Companion Medical, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190487 is the FDA 510(k) clearance record for InPen Dose Calculator, a class II device, cleared for Companion Medical, Inc. on under FDA product code NDC (Calculator, Drug Dose). FDA records list 5 510(k) clearances for Companion Medical, Inc., from to . As of , FDA records show one recall naming K190487.

Clearance record

Decision date
Received
(355 days to decision)
Product code
NDC Calculator, Drug Dose
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Companion Medical, Inc. 11011 Via Frontera, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDC

Trailing 12 months
4 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 20260