510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864619Substantially Equivalent

Caps Low Level Detector & Detector/bubble Monitor

Shiley, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864619 is the FDA 510(k) clearance record for CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR, a class II device, cleared for Shiley, Inc. on under FDA product code KRL (Detector, Bubble, Cardiopulmonary Bypass). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K864619.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KRL Detector, Bubble, Cardiopulmonary Bypass
Regulation
21 CFR 870.4205
Device class
Class II
Review panel
Cardiovascular
Applicant
Shiley, Inc. 17600 Gillette Ave., Irvine CA
Third party review
No

Clearances, product code KRL

Trailing 12 months

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

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