510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K113007Substantially Equivalent

Bionime Diabetes Management System Vi.0

Bionime Corporation, Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113007 is the FDA 510(k) clearance record for BIONIME DIABETES MANAGEMENT SYSTEM VI.0, a class I device, cleared for Bionime Corporation on under FDA product code JQP (Calculator/Data Processing Module, For Clinical Use). FDA records list 21 510(k) clearances for Bionime Corporation, from to . As of , FDA records show no recalls naming K113007.

Clearance record

Decision date
Received
(143 days to decision)
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Regulation
21 CFR 862.2100
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bionime Corporation 27001 La Paz Rd., Mission Viejo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JQP

Trailing 12 months

FDA records hold no clearances under product code JQP in the trailing twelve months.

FDA records show no clearances under product code JQP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260