510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K020587Substantially Equivalent

Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing Pv 4046

Pulsion Medical Systems AG, Concord MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020587 is the FDA 510(k) clearance record for PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046, a class II device, cleared for Pulsion Medical Systems AG on under FDA product code KRB (Probe, Thermodilution). FDA records list 8 510(k) clearances for Pulsion Medical Systems AG, from to . As of , FDA records show no recalls naming K020587.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KRB Probe, Thermodilution
Regulation
21 CFR 870.1915
Device class
Class II
Review panel
Cardiovascular
Applicant
Pulsion Medical Systems AG 100 Main St., Concord MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRB

Trailing 12 months

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

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