510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K043529Substantially Equivalent

Accu-Chek Advisor Insulin Guidance Software

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043529 is the FDA 510(k) clearance record for ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code NDC (Calculator, Drug Dose). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K043529.

Clearance record

Decision date
Received
(108 days to decision)
Product code
NDC Calculator, Drug Dose
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDC

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