# K964190: Era 300 Dual Chamber Pacing System Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jul 10, 1997 after 262 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- 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 K883930 (1988). 2 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883930: Seamed Model 3300 Dual Chamber Pacing System Analy, Seamed Corp. (1988) Summary page 1.
- K884331: Medtronic Model 5311B a-V Pacing System Analyzer, Medtronic Vascular (1989) Summary page 1.

## Most influential descendants
- K022360: Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp. (2003), 4 descendants of its own
- K083674: PK-141 Patient Cable (2009), 1 descendant of its own
- K033613: Modification to Era 300 Dual Chamber Pacing System Analyzer (2003), 1 descendant of its own
- K170815: PSA Cable (2017), 0 descendants of its own
- K123916: Psa Series (2013), 0 descendants of its own

## Indications for use
The ERA 300 is indicated for use during invasive pacing system procedures in the following activities: TEMPORARY EXTERNAL PACING To provide temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI or AOO modalities during implantable pacemaker procedures or physician evaluations. LEAD THRESHOLD DETERMINATION To determine in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. To determine the in vivo retrograde conduction time. PACEMAKER FUNCTION TEST To test and analyze the in vitro operation of external or implantable pulse generators. To determine the following parameters: pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

Source page: https://510kreport.com/device/K964190
Methodology: https://510kreport.com/methodology