510(k) · Cleared

Cleared

Meridian Hemodialysis Machine, Model 5M5576

K053539510(k) TraditionalCleared May 24, 2006155-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

Baxter Healthcare Corporation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 24, 2006 as substantially equivalent to K992894 (Baxter Healthcare Corp, 1999) after a 155-day review. Its family tree reaches back 2 generations to 1989.

Decided: May 24, 2006
Review: 155 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K883111 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883111 Heomdialysis Single Patient System (SPS) Model 650Baxter Healthcare Corp · 1989 · Recalled
1 generation backK992894 Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corp · 1999 · Recalled
This deviceK053539 Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corporation · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883111	Heomdialysis Single Patient System (SPS) Model 650	Baxter Healthcare Corp	1989	2
−1	K992894	Meridian Hemodialysis Machine, Model 5M5576	Baxter Healthcare Corp	1999	5
0 (this device)	K053539	Meridian Hemodialysis Machine, Model 5M5576	Baxter Healthcare Corporation	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K053539, 1989–2006Source: 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 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
*	K992894	Meridian Hemodialysis Machine, Model 5M5576 Summary page 1 …h Permeability Hemodialysis System (per 2ICFR 867.5860) Substantially equivalent devices Baxter Meridian Hemodialysis Machine - K992894 Description of the device The Baxter Meridian is a single patient hemoudialysis…	Baxter Healthcare Corp	1999	5

Also cleared against K992894: 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?

The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
2 of the 3 ancestors have a recall of any class.
1 other device also cites its predicate K992894.

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.

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?

Read the full statement (105 words)

The Baxter Meridian Hemodialysis Machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian machine is designed to operate in the chronic and acute dialysis environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053539 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053539: Meridian Hemodialysis Machine, Model 5M5576.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053539

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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