510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841960Substantially Equivalent

Cardio Metrics Invasive Pressure Monit

Sterile Design, Inc., Oldsmar FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841960 is the FDA 510(k) clearance record for CARDIO METRICS INVASIVE PRESSURE MONIT, a class II device, cleared for Sterile Design, Inc. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 10 510(k) clearances for Sterile Design, Inc., from to . As of , FDA records show no recalls naming K841960.

Clearance record

Decision date
Received
(543 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Sterile Design, Inc. P.O. Box 12100, Oldsmar FL
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