510(k) Report

510(k) · Cleared

Cleared

Stockert S3 Roller Pump Module Stockert S3 Console

K950990510(k) TraditionalCleared Jan 19, 1996322-day reviewClass II21 CFR 870.4220

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

Stoeckert Instrumente · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

Cleared on Jan 19, 1996 after a 322-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Jan 19, 1996
Review
322 days
Class
Class II
Product code
DTQ
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1999: 1 descendant cleared2021: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2023: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950990 Stockert S3 Roller Pump Module Stockert S3 ConsoleStoeckert Instrumente · 1996
  2. Descendant · cites it directly · 5 of its ownK071318 Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK210130 Stockert S5 SystemLivanova Deutschland, GmbH · 2021
  4. Descendant · 2 generations on · 2 of its ownK112225 Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK082344 Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 12007: 12008: 12011: 12021: 12023: 2
1999high 2 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · 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
0 (this device)K950990Stockert S3 Roller Pump Module Stockert S3 ConsoleStoeckert Instrumente1996—
+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
199910
200710
200810
201110
202110
202320
FIG. 1 — Lineage of K950990, 1996–2023Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTQ? 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 DTQ device

  1. #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH20075
K992635Interface Module IdddStoeckert Instrumente19990

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?

  • Of its descendants, K071318 (Sorin Group Deutschland GmbH, 2007) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DTQ devices

DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTQ

3in 2023

2007: 22008: 12009: 32010: 12011: 22014: 22015: 22017: 22018: 12019: 12021: 22023: 3
2007high 3 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTQ

292in 2023

2009: 86 days median2023: 292 days median
2007high 292 (2023) · low 86 (2009)2026

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

Recalls per year · DTQ

1in 2024

2007: 92008: 172009: 12010: 172011: 222012: 422013: 42014: 12018: 12019: 1, 1 Class I2022: 12023: 7, 1 Class I2024: 1
2007high 42 (2012) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DTQ

1,014in 2025

2007: 4202008: 5482009: 5892010: 8112011: 1,0812012: 1,6262013: 9062014: 1,2902015: 1,1842016: 7142017: 5272018: 6762019: 8572020: 6272021: 7292022: 7172023: 8182024: 8632025: 1,014
2007high 1,626 (2012) · low 420 (2007)2025

MAUDE reports naming product code DTQ, 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
20072—9420
20081—17548
20093861589
20101—17811
20112—221,081
20120—421,626
20130—4906
20142—11,290
20152—01,184
20160—0714
20172—0527
20181—1676
20191—1 (1)857
20200—0627
20212—0729
20220—1717
202332927 (1)818
20240—1863
20250—01,014
20260—0—

More from Stoeckert Instrumente

13 FDA decisions under this applicant name. See the company

  • K002273Stockert A272 Series Pediatric Aortic CannulaeStoeckert Instrumente · 2001
  • K001961Stockert A242 and A252 Series Arterial Femoral CannulaeStoeckert Instrumente · 2001
  • K002118Stockert Compact System Version 2.0Stoeckert Instrumente · 2000
  • K992635Interface Module IdddStoeckert Instrumente · 1999
  • K990512Stockert Power Supply Unit for S3 ComponentsStoeckert Instrumente · 1999

Recent decisions in DTQ

The DTQ category page

  • K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 20231 recall
  • K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2023
  • K221373Essenz HLMLivanova Deutschland, GmbH · 2023
  • K210130Stockert S5 SystemLivanova Deutschland, GmbH · 2021
  • K202125Century Perfusion SystemCentury Hlm, LLC · 2021

https://510kreport.com/device/K950990 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950990: Stockert S3 Roller Pump Module Stockert S3 Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950990

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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