510(k) Report

510(k) · Cleared

Cleared

DPS 4 Dialyzer Preparation System

K955299510(k) TraditionalCleared Oct 21, 1996336-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Seratronics, Inc. · LIF Dialyzer Reprocessing System

Cleared on Oct 21, 1996 as substantially equivalent to K832230 (Seratronics, Inc., 1983) after a 336-day review. Its family tree reaches back 1 generation to 1983.

Decided
Oct 21, 1996
Review
336 days
Class
Class II
Product code
LIF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K832230 (1983). No later device cites it as a predicate yet.

K832230 · Dialyzer Preparation Sys DPS-4 · Seratronics, Inc. · 19831980198519901995
K832230 · Dialyzer Preparation Sys DPS-4 · Seratronics, Inc. · 19830
  1. Root · 1 generation backK832230 Dialyzer Preparation Sys DPS-4Seratronics, Inc. · 1983
  2. This deviceK955299 DPS 4 Dialyzer Preparation SystemSeratronics, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K832230Dialyzer Preparation Sys DPS-4Seratronics, Inc.1983—
0 (this device)K955299DPS 4 Dialyzer Preparation SystemSeratronics, Inc.1996—
FIG. 1 — Lineage of K955299, 1983–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K832230Dialyzer Preparation Sys DPS-4
Summary page 2
…bmitted in the original 510(k). This machine and accessories described in this submission are substantially equivalent to the device indicated in premarket notification K832230 and to any dialysis machine to the extent that it may be used to rinse germicide or manufacturing residuals from new or reused d…
Seratronics, Inc.1983—
*—dialysis machine
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All LIF devices

LIF Dialyzer Reprocessing System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIF

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIF

Too few LIF 510(k)s in any year since 2007 to give a median.

Recalls per year · LIF

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LIF

1in 2017

2007: 32008: 12014: 12017: 1
2007high 3 (2007) · low 0 (2009)2025

MAUDE reports naming product code LIF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—01
20090—10
20101—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

This device is intended solely for processing (e.g., in vitro rinsing) of hemodialyzers. Any subsequent clinical use of the dialyzer processed by this machine is sole responsibility of the patient's physician.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Seratronics, Inc.

21 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in LIF

The LIF category page

  • K091360Clearflux Dialyzer Reprocessing SystemNovaflux Technologies · 2010
  • K043126Assist Header CleanerAlcavis International, Inc. · 2005
  • K040660Sterichek Glutaraldehyde Reagent StripsHach Company · 2004
  • K033505Renaclean SH Dialyzer Cleaning SystemMinntech Corp. · 2004
  • K024076Maky 21.1 Dialyzer Reprocessing SystemHdc Maquinolas, LLC · 2003

https://510kreport.com/device/K955299 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955299: DPS 4 Dialyzer Preparation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955299

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026