510(k) · Cleared

Cleared

Allient Sorbent Hemodialysis System, Model 1000

K043574510(k) TraditionalCleared Jun 3, 2005158-day reviewClass II21 CFR 876.5600

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

Renal Solutions, Inc. · FKT System, Dialysate Delivery, Sorbent Regenerated

Cleared on Jun 3, 2005 as substantially equivalent to K840743 (Organon Teknika Corp., 1984) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Jun 3, 2005
Review: 158 days
Class: Class II
Product code: FKT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K840743 (1984). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK840743 REDY 2000Organon Teknika Corp. · 1984
This deviceK043574 Allient Sorbent Hemodialysis System, Model 1000Renal Solutions, Inc. · 2005
Descendant · cites it directly · 0 of its ownK060381 Allient Sorbet Hemodialysis System, Model 1100Renal Solutions, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K060381Allient Sorbet Hemodialysis System, Model 1100Renal Solutions, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840743	REDY 2000	Organon Teknika Corp.	1984	—
0 (this device)	K043574	Allient Sorbent Hemodialysis System, Model 1000	Renal Solutions, Inc.	2005	—
+1	K060381	Allient Sorbet Hemodialysis System, Model 1100	Renal Solutions, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K043574, 1984–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FKT? 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

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K840743	REDY 2000 Summary page 1 …ystem Common System, Dialysate Delivery, Sorbent Regenerated Name Classification Class II per 21CFR876.5600 code FKT Predicate Device REDY 2000 (K840743 and K882428) Information Device Overview of the Allient® Sorbent Hemodialysis System Description…	Organon Teknika Corp.	1984	—
*	K882428	REDY 2000 Summary page 1 …n System, Dialysate Delivery, Sorbent Regenerated Name Classification Class II per 21CFR876.5600 code FKT Predicate Device REDY 2000 (K840743 and K882428) Information Device Overview of the Allient® Sorbent Hemodialysis System Description The All…	Organon Teknika Corp.	1988	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K060381	Allient Sorbet Hemodialysis System, Model 1100	Renal Solutions, Inc.	2006	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K060381 (Renal Solutions, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FKT devices

FKT System, Dialysate Delivery, Sorbent Regenerated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKT

1in 2013

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FKT

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

Recalls per year · FKT

No recall names FKT since 2007.

Adverse event reports per year · FKT

1in 2012

2007high 1 (2008) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	1
2009	0	—	0
2010	1	—	1
2011	0	—	1
2012	0	—	1
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Allient® Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043574 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043574: Allient Sorbent Hemodialysis System, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043574

Report an extraction error

Are you the manufacturer?

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