510(k) Report

510(k) · Cleared

Cleared

Pack H Hemodialysis Urea Kinetic Modeling Software Program

K955423510(k) TraditionalCleared Jun 13, 1996198-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

Fresenius USA, Inc. · FKP System, Dialysate Delivery, Single Patient

Cleared on Jun 13, 1996 after a 198-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jun 13, 1996
Review
198 days
Class
Class II
Product code
FKP
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955423 Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFresenius USA, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK130460 Nxstage Dosing CalculatorNxstage Medical, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K130460Nxstage Dosing CalculatorNxstage Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955423Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFresenius USA, Inc.1996—
+1K130460Nxstage Dosing CalculatorNxstage Medical, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K955423, 1996–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in FKP? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130460Nxstage Dosing CalculatorNxstage Medical, Inc.20130

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?

  • Of its descendants, K130460 (Nxstage Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FKP devices

FKP System, Dialysate Delivery, Single Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKP

1in 2018

2013: 22018: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FKP

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

Recalls per year · FKP

1in 2010

2008: 42009: 22010: 1
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FKP

4in 2021

2007: 82008: 262009: 222010: 92011: 42013: 22014: 12015: 12018: 52019: 12021: 4
2007high 26 (2008) · low 0 (2012)2025

MAUDE reports naming product code FKP, 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—08
20080—426
20090—222
20100—19
20110—04
20120—00
20132—02
20140—01
20150—01
20160—00
20170—00
20181—05
20190—01
20200—00
20210—04
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Fresenius USA, Inc.

38 FDA decisions under this applicant name. See the company

  • K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing…Fresenius USA, Inc. · 1999
  • K970700Fresenius Polysulfone Hemodialyzers, Both Low and High FluxFresenius USA, Inc. · 1998
  • K974584Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSFresenius USA, Inc. · 1998
  • K973378C.a.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model 900 510 1, PSQ Set…Fresenius USA, Inc. · 1997
  • K9614652008H on Line Clearance MonitorFresenius USA, Inc. · 1997

Recent decisions in FKP

The FKP category page

  • K181991NxStage Connected Health SystemNxstage Medical, Inc. · 2018
  • K131739Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
  • K130460Nxstage Dosing CalculatorNxstage Medical, Inc. · 2013
  • K040074Oneview InterfaceNxstage Medical, Inc. · 2004
  • K021060Fresenius Icare Monitoring SystemFresenius Medical Care North America · 2002

https://510kreport.com/device/K955423 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955423: Pack H Hemodialysis Urea Kinetic Modeling Software Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955423

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026