510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100947Substantially Equivalent

Finesse Personal Insulin Delivery Patch, Model Fg 2000

Calibra Medical, Inc., Redwood City CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100947 is the FDA 510(k) clearance record for FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000, a class II device, cleared for Calibra Medical, Inc. on under FDA product code OPP (Pump, Infusion, Insulin Bolus). FDA's definition for product code OPP reads: "The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus". FDA records list 3 510(k) clearances for Calibra Medical, Inc., from to . As of , FDA records show no recalls naming K100947.

Clearance record

Decision date
Received
(83 days to decision)
Product code
OPP Pump, Infusion, Insulin Bolus
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Calibra Medical, Inc. 220 Saginaw Dr., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OPP

Trailing 12 months
1 clearance under product code OPP in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OPP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260