510(k) · Cleared

Cleared

The Cdi (R) System 400

K890113510(k) TraditionalCleared May 23, 1989132-day reviewClass I21 CFR 862.2230

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

Cardiovascular Devices, Inc. · DJY Ion-Exchange Chromatography

Cleared on May 23, 1989 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.

Decided: May 23, 1989
Review: 132 days
Class: Class I
Product code: DJY
Recalls: None
Predicates: 0

13 later devices descend from it, 2 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.

This deviceK890113 The Cdi (R) System 400Cardiovascular Devices, Inc. · 1989
Descendant · cites it directly · 10 of its ownK972962 3M Cdi Blood Parameter Monitoring System 5003M Company · 1997 · Recalled
Descendant · 2 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
Descendant · 3 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
Descendant · 2 generations on · 3 of its ownK090147 Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · Recalled
Descendant · 4 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997high 2 (2011) · low 0 (1999)2026

Class I recalls in this family

K102726 Cardiohelp System3 generations on · 2011
K133598 Cardiohelp System4 generations on · 2014

Most influential descendants

Showing 5 of 13 · See all

K9729623M Cdi Blood Parameter Monitoring System 5003M Company · 1997 · cites it directly10descendants
K110957M4 MonitorSpectrum Medical, Llp · 2011 · 2 generations on4descendants
K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 3 generations on3descendants
K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · 2 generations on3descendants
K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K890113	The Cdi (R) System 400	Cardiovascular Devices, Inc.	1989	—
+1	K972962	3M Cdi Blood Parameter Monitoring System 500	3M Company	1997	26
+2	K110957	M4 Monitor	Spectrum Medical, Llp	2011	—
+3	K173591	Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas	Spectrum Medical, Ltd.	2018	—
+2	K090147	Blood Monitoring Unit, Model Bmu 40	Maquet Cardiopulmonary, AG	2009	1
+4	K181942	Quantum Ventilation Module	Spectrum Medical, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2009	1	0
2011	2	1
2012	1	0
2013	1	0
2014	2	1
2018	2	0
2020	1	0
2021	1	0

FIG. 1 — Lineage of K890113, 1989–2021Source: 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.

2 devices in this family have a Class I recall. 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?

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

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K972962	3M Cdi Blood Parameter Monitoring System 500	3M Company	1997	10
K980732	3M Cdi Quick-Cells with Heparin Treatment	3M Healthcare	1998	1

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K972962 (3M Company, 1997) has gone furthest, with 10 descendants of its own.

How does its category compare?

All DJY devices

DJY Ion-Exchange Chromatography: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DJY

FDA has decided no DJY device since 2007.

Median 510(k) review, days · DJY

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

Recalls per year · DJY

No recall names DJY since 2007.

Adverse event reports per year · DJY

No MAUDE report names DJY since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
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/K890113 · printed Nov 4, 2026

Cite this page

510(k) Report. “K890113: The Cdi (R) System 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890113

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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