# K910307: Cardiolab Amplifier Module (Cam)

- Pathway: 510(k) (Traditional)
- Applicant: Prucka Engineering, Inc.
- Decided: Apr 12, 1991 after 78 days
- Product code: DRR (Amplifier And Signal Conditioner, Biopotential)
- Device class: 2
- Regulation: 21 CFR 870.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971570: Epxpress System (Timberwolf Revision) /000391 (1997), 19 descendants of its own
- K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2 (2000), 18 descendants of its own
- K020440: Newcor (2002), 9 descendants of its own
- K071348: Ems-XL Cardiac Electrophysiology System (2007), 7 descendants of its own
- K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System (2014), 5 descendants of its own

Source page: https://510kreport.com/device/K910307
Methodology: https://510kreport.com/methodology