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
K850568Substantially Equivalent

Model 78231D Cardiac Output Module

Hewlett-Packard Co., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850568 is the FDA 510(k) clearance record for MODEL 78231D CARDIAC OUTPUT MODULE, a class II device, cleared for Hewlett-Packard Co. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K850568.

Clearance record

Decision date
Received
(56 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
Hewlett-Packard Co. 175 Waltham St., Waltham MA
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