510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915337Substantially Equivalent

Capiox Level Alarm

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915337 is the FDA 510(k) clearance record for CAPIOX LEVEL ALARM, a class II device, cleared for Terumo Medical Corp. on under FDA product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K915337.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Regulation
21 CFR 870.4340
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Medical Corp. P.O. Box 605, Elkton MD
510(k) summary
Statement
Third party review
No

Clearances, product code DTW

Trailing 12 months

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

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