510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863308Substantially Equivalent

2200I Physiological Monitor

Datascope Corp., Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863308 is the FDA 510(k) clearance record for 2200I PHYSIOLOGICAL MONITOR, a class II device, cleared for Datascope Corp. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show no recalls naming K863308.

Clearance record

Decision date
Received
(130 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
Datascope Corp. 580 Winters Ave., Paramus NJ
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