510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851077Substantially Equivalent

Cardiac Cooling Jacket

Pat O. Daily, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851077 is the FDA 510(k) clearance record for CARDIAC COOLING JACKET, a class I device, cleared for Pat O. Daily on under FDA product code KRI (Accessory Equipment, Cardiopulmonary Bypass). FDA records list 2 510(k) clearances for Pat O. Daily, from to . As of , FDA records show no recalls naming K851077.

Clearance record

Decision date
Received
(115 days to decision)
Product code
KRI Accessory Equipment, Cardiopulmonary Bypass
Regulation
21 CFR 870.4200
Device class
Class I
Review panel
Cardiovascular
Applicant
Pat O. Daily 7930 Frost St., San Diego CA
Third party review
No

Clearances, product code KRI

Trailing 12 months

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

FDA records show no clearances under product code KRI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KRI, 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