# K182905: UniPulse

- Pathway: 510(k) (Traditional)
- Applicant: Seaward Group
- Decided: Dec 14, 2018 after 59 days
- Product code: DRL (Tester, Defibrillator)
- Device class: 2
- Regulation: 21 CFR 870.5325
- 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 K072114 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072114: Impulse 6000D/7000DP, Fluke Biomedical (2008) Summary page 5.

## Indications for use
The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator and a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients.

Source page: https://510kreport.com/device/K182905
Methodology: https://510kreport.com/methodology