510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K161865Substantially Equivalent

iSage Rx (iSage Rx Basal Insulin Titration)

Isag Rx, Inc., Wilmington DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161865 is the FDA 510(k) clearance record for iSage Rx (iSage Rx Basal Insulin Titration), a class II device, cleared for Isag Rx, Inc. on under FDA product code NDC (Calculator, Drug Dose). FDA records list one 510(k) clearance for Isag Rx, Inc. As of , FDA records show no recalls naming K161865.

Clearance record

Decision date
Received
(243 days to decision)
Product code
NDC Calculator, Drug Dose
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Isag Rx, Inc. 206 Alapocas Dr., Wilmington DE
510(k) summary
Statement
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