510(k) Report

FDA applicant

Seratronics, Inc.

Concord, CA21 decisions1982–19961 recall

FDA records 21 decisions for Seratronics, Inc. (Concord, CA) from 1982 to 1996: 21 510(k) clearances. Most are in product codes LIF (Dialyzer Reprocessing System) and KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Seratronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seratronics, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Seratronics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LIFDialyzer Reprocessing System9decisions
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System6decisions
  • FJIDialyzer, Capillary, Hollow Fiber2decisions
  • FKQSystem, Dialysate Delivery, Central Multiple Patient2decisions
  • FLCStation, Dialysis Control, Negative Pressure Type1decision
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

Who builds on its devices?

Later devices cite its devices 9 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K860674DRS-4 Dialyzer Reprocessing SystemSeratronics, Inc. · 19862cite it
  • K914580DRS-4 Dialyzer Reprocessing SystemSeratronics, Inc. · 19921cites it
  • K931336DRS 4 Dialyzer Reprocessing SystemSeratronics, Inc. · 19961cites it
  • K874872Fresenius Hemoflow F3, F4, F5, F7Seratronics, Inc. · 19881cites it
  • K852251Fresenius Hemoflow F60 & Fresenius Hemoflow F40Seratronics, Inc. · 19851cites it
  • K832230Dialyzer Preparation Sys DPS-4Seratronics, Inc. · 19831cites it

What has FDA decided for it lately?

  • K955299DPS 4 Dialyzer Preparation SystemSeratronics, Inc. · 1996
  • K931336DRS 4 Dialyzer Reprocessing SystemSeratronics, Inc. · 1996
  • K944539DRS 4 ND Dialyzer Reprocessing SystemSeratronics, Inc. · 1995
  • K923529DMS Data Management System/DRS-4 Dialyzer ReprocesSeratronics, Inc. · 1994
  • K914580DRS-4 Dialyzer Reprocessing SystemSeratronics, Inc. · 1992
  • K874573Fresenius Puristeril 340 (TM)Seratronics, Inc. · 1988
  • K874872Fresenius Hemoflow F3, F4, F5, F7Seratronics, Inc. · 19881 recall
  • K870725Fresenius Hemoflow F6 and F8Seratronics, Inc. · 1987

All 21 as Seratronics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K874872Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic…Feb 26, 2016Class II