510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850898Substantially Equivalent

Medi-Trace Disposable Pressure Transducer

Medi-Trace Products Division, Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850898 is the FDA 510(k) clearance record for MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER, a class II device, cleared for Medi-Trace Products Division on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list one 510(k) clearance for Medi-Trace Products Division. As of , FDA records show no recalls naming K850898.

Clearance record

Decision date
Received
(143 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Medi-Trace Products Division 189 Van Rensselaer St., Buffalo NY
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, 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 20261
October 20260