510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K872889Substantially Equivalent

Romeo(tm) Model 1000

Diva Medical Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872889 is the FDA 510(k) clearance record for ROMEO(TM) MODEL 1000, a class II device, cleared for Diva Medical Systems, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list one 510(k) clearance for Diva Medical Systems, Inc. As of , FDA records show no recalls naming K872889.

Clearance record

Decision date
Received
(265 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diva Medical Systems, Inc. Riverplace, Suite 214, Minneapolis MN
Third party review
No

Clearances, product code CGA

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