510(k) · Cleared

Recalled · 2004

Hemodialysis (SPS), Model 550, Code 5M1309

K872364510(k) TraditionalCleared Oct 13, 1987117-day reviewClass II21 CFR 876.5860Recalls 2

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

Travenol Laboratories, S.A. · FII System, Dialysate Delivery, Sealed

Cleared on Oct 13, 1987 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it. It has been recalled 2 times.

Decided: Oct 13, 1987
Review: 117 days
Class: Class II
Product code: FII
Recalls: 2
Predicates: 0

30 later devices descend from it, 1 citing it directly.

This deviceK872364 Hemodialysis (SPS), Model 550, Code 5M1309Travenol Laboratories, S.A. · 1987
Descendant · cites it directly · 29 of its ownK030470 Nxstage System OneNxstage Medical, Inc. · 2003
Descendant · 2 generations on · 28 of its ownK041424 Nxstage System OneNxstage Medical, Inc. · 2004
Descendant · 3 generations on · 27 of its ownK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
Descendant · 4 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
Descendant · 5 generations on · 20 of its ownK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003high 6 (2013) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all

K030470Nxstage System OneNxstage Medical, Inc. · 2003 · cites it directly29descendants
K041424Nxstage System OneNxstage Medical, Inc. · 2004 · 2 generations on28descendants
K050525Nxstage System OneNxstage Medical, Inc. · 2005 · 3 generations on27descendants
K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 4 generations on26descendants
K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009 · 5 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872364	Hemodialysis (SPS), Model 550, Code 5M1309	Travenol Laboratories, S.A.	1987	—
+1	K030470	Nxstage System One	Nxstage Medical, Inc.	2003	—
+2	K041424	Nxstage System One	Nxstage Medical, Inc.	2004	—
+3	K050525	Nxstage System One	Nxstage Medical, Inc.	2005	2
+4	K062079	Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210	Baxter Healthcare Corporation	2006	—
+5	K083778	Xenium XPH, Models 110, 130, 150, 170, 190 and 210	Baxter Healthcare Corporation	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2008	1	0
2009	1	0
2010	1	0
2013	6	0
2014	2	0
2015	1	0
2016	1	0
2017	2	0
2020	3	0
2023	1	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K872364, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FII? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K030470	Nxstage System One	Nxstage Medical, Inc.	2003	29

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 14, 2004	Not classified	Z-0367-05	Other	Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
Feb 20, 2003	Not classified	Z-0660-03	Other	Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K030470 (Nxstage Medical, Inc., 2003) has gone furthest, with 29 descendants of its own.

How does its category compare?

All FII devices

FII System, Dialysate Delivery, Sealed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FII

FDA has decided no FII device since 2007.

Median 510(k) review, days · FII

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

Recalls per year · FII

No recall names FII since 2007.

Adverse event reports per year · FII

2in 2014

2007high 204 (2007) · low 0 (2011)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	204
2008	—	109
2009	—	55
2010	—	17
2011	—	0
2012	—	3
2013	—	3
2014	—	2
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K872364 · printed Nov 4, 2026

Cite this page

510(k) Report. “K872364: Hemodialysis (SPS), Model 550, Code 5M1309.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872364

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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