510(k) · Cleared

Cleared

Hemoconcentrator

K123288510(k) TraditionalCleared Jun 26, 2013247-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

Maquet Cardiopulmonary, AG · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Jun 26, 2013 as substantially equivalent to K983085 (Minntech Corp., 1998) and 1 other predicate after a 247-day review. Its family tree reaches back 1 generation to 1994.

Decided: Jun 26, 2013
Review: 247 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K923139 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK923139 Hemocor HP Hemoconcentrator SeriesMinntech Corp. · 1994 · Recalled
This deviceK123288 HemoconcentratorMaquet Cardiopulmonary, AG · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923139	Hemocor HP Hemoconcentrator Series	Minntech Corp.	1994	1
0 (this device)	K123288	Hemoconcentrator	Maquet Cardiopulmonary, AG	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K123288, 1994–2013Source: 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? (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
*	K983085	Hemocor HPH 700 Hemoconcentrator Summary page 1 …0 plus, BC 140 plus Hemoconcentrator High Permeability Hemodialysis System Hemoconcentrator (21 CFR 876.5860 ~ Product Code: KDI) Hemocor HPH® 700, Minntech Corp. USA, K983085 Hemocor HPH® 1400, Minntech Corp. USA, K923139 BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from t…	Minntech Corp.	1998	2
*	K923139	Hemocor HP Hemoconcentrator Series Summary page 1 …ability Hemodialysis System Hemoconcentrator (21 CFR 876.5860 ~ Product Code: KDI) Hemocor HPH® 700, Minntech Corp. USA, K983085 Hemocor HPH® 1400, Minntech Corp. USA, K923139 BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary…	Minntech Corp.	1994	1

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?

2 of the 2 ancestors have a recall of any class.

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. 2013, 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 MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures.

The maximum duration of use is 6 hours.

The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K123288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123288: Hemoconcentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123288

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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