510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860076Substantially Equivalent

Gambro Ultrasonic Blood Level Detector Uld 10-200

Gambro, Inc., Lincolnshire IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860076 is the FDA 510(k) clearance record for GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200, a class II device, cleared for Gambro, Inc. on under FDA product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K860076.

Clearance record

Decision date
Received
(142 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
Gambro, Inc. 600 Knightsbridge Pkwy., Lincolnshire IL
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