510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K880830Substantially Equivalent

Sentorr Arterial Pressure Sensor

GE Healthcare, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880830 is the FDA 510(k) clearance record for SENTORR ARTERIAL PRESSURE SENSOR, a class II device, cleared for Ohmeda Medical on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K880830.

Clearance record

Decision date
Received
(164 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Ohmeda Medical 2007 Pan Am Cir., Tampa FL
Third party review
No

Clearances, product code DXO

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