# K884331: Medtronic Model 5311B a-V Pacing System Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jan 10, 1989 after 88 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K964190: Era 300 Dual Chamber Pacing System Analyzer (1997), 9 descendants of its own
- 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
- K971474: Medtronic Model 5318 Temporary Pacemaker/Implant Tool (1997), 2 descendants of its own
- K182839: Lifetech Cardio Model 8301 Temporary Pacemaker (2019), 1 descendant of its own
- K083674: PK-141 Patient Cable (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K884331
Methodology: https://510kreport.com/methodology