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
K821863Substantially Equivalent

Dialyzer Reprocessing System Drs-4

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

K821863 is the FDA 510(k) clearance record for DIALYZER REPROCESSING SYSTEM DRS-4, a class II device, cleared for Seratronics, Inc. on under FDA product code LIF (Dialyzer Reprocessing System). FDA records list 21 510(k) clearances for Seratronics, Inc., from to . As of , FDA records show no recalls naming K821863.

Clearance record

Decision date
Received
(116 days to decision)
Product code
LIF Dialyzer Reprocessing System
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Seratronics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LIF

Trailing 12 months

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

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