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
SUBSCRIBE / SIGN IN
K831402Substantially Equivalent

Pressure Monitor & Control Unit Apc-02A

Parker Hannifin Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831402 is the FDA 510(k) clearance record for PRESSURE MONITOR & CONTROL UNIT APC-02A, a class II device, cleared for Parker Hannifin Corp. on under FDA product code KXM (System Accessories, Extracorporeal). FDA records list 14 510(k) clearances for Parker Hannifin Corp., from to . As of , FDA records show no recalls naming K831402.

Clearance record

Decision date
Received
(98 days to decision)
Product code
KXM System Accessories, Extracorporeal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Parker Hannifin Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KXM

Trailing 12 months

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

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