510(k) Report

510(k) · Cleared

Cleared

Stockert SCP Rhythm

K042374510(k) SpecialCleared Sep 23, 200422-day reviewClass II21 CFR 870.4380

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

Stockert Instrumente GmbH · DWA Control, Pump Speed, Cardiopulmonary Bypass

Cleared on Sep 23, 2004 as substantially equivalent to K971520 (Stoeckert Instrumente, 1997) after a 22-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.

Decided
Sep 23, 2004
Review
22 days
Class
Class II
Product code
DWA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K971520 (1997). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2021: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2023: 2 descendants clearedK971520 · S3 Cyclic RPM Control · Stoeckert Instrumente · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K971520 · S3 Cyclic RPM Control · Stoeckert Instrumente · 19970
  1. Root · 1 generation backK971520 S3 Cyclic RPM ControlStoeckert Instrumente · 1997
  2. This deviceK042374 Stockert SCP RhythmStockert Instrumente GmbH · 2004
  3. Descendant · cites it directly · 5 of its ownK071318 Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK210130 Stockert S5 SystemLivanova Deutschland, GmbH · 2021
  5. Descendant · 2 generations on · 2 of its ownK112225 Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK082344 Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · Recalled
  7. Descendant · 3 generations on · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12011: 12021: 12023: 2
2007high 2 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · cites it directly5descendants
  • K210130Stockert S5 SystemLivanova Deutschland, GmbH · 2021 · 2 generations on2descendants
  • K112225Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · 2 generations on2descendants
  • K082344Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · 2 generations on2descendants
  • K221373Essenz HLMLivanova Deutschland, GmbH · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971520S3 Cyclic RPM ControlStoeckert Instrumente1997—
0 (this device)K042374Stockert SCP RhythmStockert Instrumente GmbH2004—
+1K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH200713
+2K210130Stockert S5 SystemLivanova Deutschland, GmbH2021—
+2K112225Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH20114
+2K082344Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH20081
+3K221373Essenz HLMLivanova Deutschland, GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201110
202110
202320
FIG. 1 — Lineage of K042374, 1997–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DWA? 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 DWA device

  1. #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K971520S3 Cyclic RPM Control
Summary page 1
…: Cyclic RPM Control Classification Name: Accessory to cardiopulmonary bypass console 3. PREDICATE DEVICE St6ckert S3 Cyclic RPM Control Module (K971520) 4. DEVICE DESCRIPTION The StOckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The mo…
Stoeckert Instrumente1997—

Also cleared against K971520: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH20075

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.
  • Of its descendants, K071318 (Sorin Group Deutschland GmbH, 2007) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K971520.

How does its category compare?

All DWA devices

DWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWA

1in 2024

2007: 12008: 32009: 22010: 22011: 22013: 22019: 12020: 22023: 22024: 1
2007high 3 (2008) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWA

44in 2008

2008: 44 days median
2007high 44 (2008)2026

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

Recalls per year · DWA

1in 2022

2010: 12012: 32013: 12017: 12021: 12022: 1, 1 Class I
2007high 3 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DWA

362in 2025

2007: 102008: 102009: 172010: 1102011: 1472012: 1022013: 1002014: 982015: 1032016: 1092017: 1402018: 2002019: 3762020: 1462021: 1552022: 2052023: 4382024: 3892025: 362
2007high 438 (2023) · low 10 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—010
2008344010
20092—017
20102—1110
20112—0147
20120—3102
20132—1100
20140—098
20150—0103
20160—0109
20170—1140
20180—0200
20191—0376
20202—0146
20210—1155
20220—1 (1)205
20232—0438
20241—0389
20250—0362
20260—0—

What is it indicated for?

The St6ckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stdckert SCP during cardiopulmonary bypass for periods of up to six hours.

Indications for use as stated in the FDA summary.

Also cleared against K971520

1 other device cites the same predicate.

  • K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 200713 recalls

More from Stockert Instrumente GmbH

9 FDA decisions under this applicant name. See the company

  • K041558Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH · 2004
  • K032213Stockert Centrifugal Pump System with Tubing ClampStockert Instrumente GmbH · 2003
  • K023622Stockert Pediatric Aortic Cannulae, Model Numbers A272-15 Through A272-35Stockert Instrumente GmbH · 2002
  • K022280Stockert Coronary Perfusion CannulaeStockert Instrumente GmbH · 2002
  • K022321Stockert V172-28 Venous Femoral CannulaStockert Instrumente GmbH · 2002

Recent decisions in DWA

The DWA category page

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  • K230698Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
  • K221491Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
  • K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical, Ltd. · 2020
  • K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous)…Abbott (Formerly Thoratec Corporation) · 2020

https://510kreport.com/device/K042374 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042374: Stockert SCP Rhythm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042374

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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