510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K893830Substantially Equivalent

Hemo-Alert

Koregon Enterprise, Inc., Beaverton OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893830 is the FDA 510(k) clearance record for HEMO-ALERT, a class II device, cleared for Koregon Enterprise, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list one 510(k) clearance for Koregon Enterprise, Inc. As of , FDA records show no recalls naming K893830.

Clearance record

Decision date
Received
(141 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Koregon Enterprise, Inc. 9735 SW Sunshine Ct.,, Beaverton OR
Third party review
No

Clearances, product code DQO

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