510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855001Substantially Equivalent

Fresenius Hemodialysis Machine A1008 Bsm

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

K855001 is the FDA 510(k) clearance record for FRESENIUS HEMODIALYSIS MACHINE A1008 BSM, a class II device, cleared for Seratronics, Inc. on under FDA product code FLC (Station, Dialysis Control, Negative Pressure Type). FDA records list 21 510(k) clearances for Seratronics, Inc., from to . As of , FDA records show no recalls naming K855001.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FLC Station, Dialysis Control, Negative Pressure Type
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Seratronics, Inc. 4090 Pike Ln., Concord CA
Third party review
No

Clearances, product code FLC

Trailing 12 months

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

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