510(k) · Cleared

Cleared

NxStage Therapeutic Plasma Exchange (TPE) Cartridge

K143313510(k) TraditionalCleared Mar 20, 2015121-day reviewClass II21 CFR 876.5860

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

Nxstage Medical, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Mar 20, 2015 as substantially equivalent to K093069 (Nxstage Medical, Inc., 2010) after a 121-day review. Its family tree reaches back 1 generation to 2010.

Decided: Mar 20, 2015
Review: 121 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K093069 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK093069 Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 2010
This deviceK143313 NxStage Therapeutic Plasma Exchange (TPE) CartridgeNxstage Medical, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K093069	Nxstage System One with Therapeutic Plasma Exchange Cartridge	Nxstage Medical, Inc.	2010	—
0 (this device)	K143313	NxStage Therapeutic Plasma Exchange (TPE) Cartridge	Nxstage Medical, Inc.	2015	—

FIG. 1 — Lineage of K143313, 2010–2015Source: 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 KDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KDI device

#1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K093069	Nxstage System One with Therapeutic Plasma Exchange Cartridge Summary page 5 …Class II Device Panel: Gastroenterology/Urology D. Legally Marketed Predicate Device NxStage TPE Cartridge, 510k number K093069 cleared on October 23, 2010 E. Device Description/Indications for Use: The NxStage TPE Cartridge provides therapeutic plasma…	Nxstage Medical, Inc.	2010	—
†	P820033	Plasmaflo OP-05 W (a) Asahi Plasma Separator	Asahi Kasei Medical Co., Ltd.	1983	—

Also cleared against K093069: 1 other device →

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.
1 other device also cites its predicate K093069.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · KDI

9in 2025

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	91	4	916
2008	6	148	0	1,042
2009	4	236	3	522
2010	9	186	1	823
2011	5	85	4	2,270
2012	6	153	1	1,765
2013	11	247	2	2,360
2014	8	164	3	6,154
2015	5	69	5	4,182
2016	5	230	4	766
2017	8	188	1	963
2018	2	—	1	1,716
2019	4	263	6	1,587
2020	9	266	0	1,633
2021	2	—	2	1,944
2022	7	259	17	2,180
2023	7	157	8 (8)	2,692
2024	7	235	4 (2)	2,441
2025	9	199	2	2,786
2026	6	154	2	—

What is it indicated for?

The NxStage TPE Cartridge is indicated for use only with the NxStage System One for therapeutic plasma exchange in a clinical environment.

All treatments must be administered under a physician’s prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143313: NxStage Therapeutic Plasma Exchange (TPE) Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143313

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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