# 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.

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jan 27, 2003 after 192 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.
4 later devices descend from it; 3 cite it directly.
0 of 8 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
- K083674: PK-141 Patient Cable (2009), 1 descendant of its own
- K170815: PSA Cable (2017), 0 descendants of its own
- K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 (2010), 0 descendants of its own
- K042708: Era 3000 Pacing System Analyzer (2004), 0 descendants of its own

## Indications for use
The ERA 3000 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, MI, AOO, or OD0 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, AN delay, and rate/interval.

Source page: https://510kreport.com/device/K022360
Methodology: https://510kreport.com/methodology