510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091786Substantially Equivalent

Pulsion Picco2 (8500), Cevox Optical Module (Pc3015), Cevox Disposable Probes (Pv2022-30 Thru -38, Pv2022-46 Thru -48)

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

K091786 is the FDA 510(k) clearance record for PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48), a class II device, cleared for Pulsion Medical Systems AG on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 8 510(k) clearances for Pulsion Medical Systems AG, from to . As of , FDA records show no recalls naming K091786.

Clearance record

Decision date
Received
(366 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 AG 7220 Sparhawk Rd., Wake Forest NC
510(k) summary
Summary PDF
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