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
K772161Substantially Equivalent

Hemodialysis Apparatus

Heald Manufacturing, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K772161 is the FDA 510(k) clearance record for HEMODIALYSIS APPARATUS, a class II device, cleared for Heald Manufacturing, Inc. on under FDA product code FKQ (System, Dialysate Delivery, Central Multiple Patient). FDA records list one 510(k) clearance for Heald Manufacturing, Inc. As of , FDA records show no recalls naming K772161.

Clearance record

Decision date
Received
(48 days to decision)
Product code
FKQ System, Dialysate Delivery, Central Multiple Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Heald Manufacturing, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKQ

Trailing 12 months

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

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