510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122121Substantially Equivalent

Pulsioflex Monitoring System with Picco Module

Pulsion Medical Systems SE, Westbrook CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K122121 is the FDA 510(k) clearance record for PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE, a class II device, cleared for Pulsion Medical Systems SE on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 4 510(k) clearances for Pulsion Medical Systems SE, from to . As of , FDA records show no recalls naming K122121.

Clearance record

Decision date
Received
(16 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Pulsion Medical Systems SE 1511 Essex Rd., Westbrook CT
510(k) summary
Statement
Third party review
No

Clearances, product code DXG

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