510(k) Report

510(k) · Cleared

Cleared

Interface Module Iddd

K992635510(k) SpecialCleared Dec 20, 1999136-day reviewClass I21 CFR 870.4200

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

Stoeckert Instrumente · KRI Accessory Equipment, Cardiopulmonary Bypass

Cleared on Dec 20, 1999 as substantially equivalent to K950990 (Stoeckert Instrumente, 1996) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1996.

Decided
Dec 20, 1999
Review
136 days
Class
Class I
Product code
KRI
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K950990 (1996). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK950990 · Stockert S3 Roller Pump Module Stockert S3 Console · Stoeckert Instrumente · 1996199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K950990 · Stockert S3 Roller Pump Module Stockert S3 Console · Stoeckert Instrumente · 19960
  1. Root · 1 generation backK950990 Stockert S3 Roller Pump Module Stockert S3 ConsoleStoeckert Instrumente · 1996
  2. This deviceK992635 Interface Module IdddStoeckert Instrumente · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950990Stockert S3 Roller Pump Module Stockert S3 ConsoleStoeckert Instrumente1996—
0 (this device)K992635Interface Module IdddStoeckert Instrumente1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K992635, 1996–1999Source: 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 KRI? 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K950990Stockert S3 Roller Pump Module Stockert S3 Console
Summary page 1
…monary bypass heart lung machine 3. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED Stockert S3 Heart Lung Machine (K950990) Stockert SC Heart Lung System (K982014) Stockert-Shiley HLM Interface Module (K983541) 4. DEVICE DESCRIPTION The Stockert Inte…
Stoeckert Instrumente1996—
*K982014Stockert Compact System
Summary page 1
…NTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED Stockert S3 Heart Lung Machine (K950990) Stockert SC Heart Lung System (K982014) Stockert-Shiley HLM Interface Module (K983541) 4. DEVICE DESCRIPTION The Stockert Interface Module IDDD is an addition to the…
Stoeckert Instrumente1998—
Kept off the family treeK983541FDA’s K983541 is HSV 1+2 Igg Elisa Test
Our OCR of the scanned summary read K983541, FDA’s number for HSV 1+2 Igg Elisa Test (Gull Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stockert-Shiley HLM Interface Module”. Kept off the family tree.
Summary page 1
…D DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED Stockert S3 Heart Lung Machine (K950990) Stockert SC Heart Lung System (K982014) Stockert-Shiley HLM Interface Module (K983541) 4. DEVICE DESCRIPTION The Stockert Interface Module IDDD is an addition to the Stockert S3 heart lung machine (K950990) and th…
Gull Laboratories, Inc.1999—

Also cleared against K950990: 1 other device →

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K950990.

How does its category compare?

All KRI devices

KRI Accessory Equipment, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRI

FDA has decided no KRI device since 2007.

Median 510(k) review, days · KRI

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

Recalls per year · KRI

2in 2011

2009: 32011: 2
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRI

5in 2023

2014: 32016: 12021: 12022: 22023: 5
2007high 5 (2023) · low 0 (2007)2025

MAUDE reports naming product code KRI, 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
20070—00
20080—00
20090—30
20100—00
20110—20
20120—00
20130—00
20140—03
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—01
20220—02
20230—05
20240—00
20250—00
20260—0—

What is it indicated for?

The Stockert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for car(liopulmonary bypass. The Interface Module IDDD provi(les serial data output from the Stsckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the…

Read the full statement (119 words)

The Stockert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for car(liopulmonary bypass. The Interface Module IDDD provi(les serial data output from the Stsckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a completé overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for malzing clinical decisions for cliagnosis.

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

Also cleared against K950990

1 other device cites the same predicate.

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

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
  • K990512Stockert Power Supply Unit for S3 ComponentsStoeckert Instrumente · 1999
  • K982014Stockert Compact SystemStoeckert Instrumente · 1998

Recent decisions in KRI

The KRI category page

  • K0203653TM Myocardial Needle-Temperature Probe3t Medical Systems, LLC · 2002
  • K990512Stockert Power Supply Unit for S3 ComponentsStoeckert Instrumente · 1999
  • K934782Ammex Tubing OrganizerAmmex Cardiopulmonary Corp. · 1993
  • K926233CARDIO2 CycleErgometrix, Inc. · 1993
  • K922404Tube GripGeorgia Medical Products, Inc. · 1992

https://510kreport.com/device/K992635 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992635: Interface Module Iddd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992635

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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