# K903966: External Pacemaker Analyzer Model Pma-1

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Jun 19, 1991 after 295 days
- Product code: DTC (Analyzer, Pacemaker Generator Function)
- Device class: 2
- Regulation: 21 CFR 870.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K011729: Sigma Pace External Pacemaker Analyzer Model #1000 (2001), 0 descendants of its own
- K954391: Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter (1995), 0 descendants of its own

Source page: https://510kreport.com/device/K903966
Methodology: https://510kreport.com/methodology