# K992635: Interface Module Iddd

- Pathway: 510(k) (Special)
- Applicant: Stoeckert Instrumente
- Decided: Dec 20, 1999 after 136 days
- Product code: KRI (Accessory Equipment, Cardiopulmonary Bypass)
- Device class: 1
- Regulation: 21 CFR 870.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950990 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950990: Stockert S3 Roller Pump Module Stockert S3 Console, Stoeckert Instrumente (1996) Summary page 1.
- K982014: Stockert Compact System, Stoeckert Instrumente (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K983541: HSV 1+2 Igg Elisa Test, Gull Laboratories, Inc. (1999). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K992635
Methodology: https://510kreport.com/methodology