# K073230: Models Era 300 and 3105 Pacing System Analyzers

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Dec 20, 2007 after 35 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: 3 generations back to K883930 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
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.
- K033613: Modification to Era 300 Dual Chamber Pacing System Analyzer, Biotronik, Inc. (2003) Summary page 1.

## Indications for use
The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: a Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, 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/K073230
Methodology: https://510kreport.com/methodology