# K033613: Modification to Era 300 Dual Chamber Pacing System Analyzer

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Dec 8, 2003 after 21 days
- Product code: DTA (Tester, Pacemaker Electrode Function)
- Device class: 2
- Regulation: 21 CFR 870.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883930 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964190: Era 300 Dual Chamber Pacing System Analyzer, Biotronik, Inc. (1997) Summary page 1.

## Most influential descendants
- K073230: Models Era 300 and 3105 Pacing System Analyzers (2007), 0 descendants of its own

## Indications for use
The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: · Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, WI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. * Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. * Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

Source page: https://510kreport.com/device/K033613
Methodology: https://510kreport.com/methodology