510(k) · Cleared

Recalled · 2011

Sams 8000 Cardioplegia Monitor

K960916510(k) TraditionalCleared Jun 4, 199690-day reviewClass II21 CFR 870.1100Recalls 1

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

3M Health Care, Sarns · DSJ Alarm, Blood-Pressure

Cleared on Jun 4, 1996 as substantially equivalent to K915183 (3M Health Care, Sarns, 1992) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1987. It has been recalled once.

Decided: Jun 4, 1996
Review: 90 days
Class: Class II
Product code: DSJ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K871131 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK871131 Sarns 9000 Heart-Lung Console3M Health Care, Sarns · 1987 · Recalled
This deviceK960916 Sams 8000 Cardioplegia Monitor3M Health Care, Sarns · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871131	Sarns 9000 Heart-Lung Console	3M Health Care, Sarns	1987	14
0 (this device)	K960916	Sams 8000 Cardioplegia Monitor	3M Health Care, Sarns	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

FIG. 1 — Lineage of K960916, 1987–1996Source: 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 DSJ? 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? (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
*	K915183	Sarns 8000 Modular Perfusion System Summary page 1 …blood pump" (21 CFR 870.4370). Predicate Devices: The new Sarns 8000 Cardioplegia Monitor is substantially equivalent to the existing Sarns 8000 Cardioplegia Monitor (K915183) and the Sarns 9000 Cardioplegia Control (K871131). Device Description: The Sarns 8000 Cardioplegia Monitor is only compatible…	3M Health Care, Sarns	1992	45
*	K871131	Sarns 9000 Heart-Lung Console Summary page 1 …: The new Sarns 8000 Cardioplegia Monitor is substantially equivalent to the existing Sarns 8000 Cardioplegia Monitor (K915183) and the Sarns 9000 Cardioplegia Control (K871131). Device Description: The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The…	3M Health Care, Sarns	1987	14

Also cleared against K915183: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 29, 2011	Not classified	Z-3214-2011	Component change control	The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

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.
2 other devices also cite its predicate K915183.

How does its category compare?

All DSJ devices

DSJ Alarm, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSJ

1in 2019

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSJ

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

Recalls per year · DSJ

No recall names DSJ since 2007.

Adverse event reports per year · DSJ

6in 2025

2007high 32 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	1	—	2
2016	0	—	0
2017	1	—	1
2018	0	—	0
2019	1	—	2
2020	0	—	0
2021	0	—	32
2022	0	—	27
2023	0	—	16
2024	0	—	30
2025	0	—	6
2026	0	—	—

What is it indicated for?

The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit, either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardioplegia doses, and tracks the volume of cardioplegia delivered.

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/K960916 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960916: Sams 8000 Cardioplegia Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960916

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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