# K895379: Low Energy DC - Defibrillator (Including Paddles)

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Feb 26, 1990 after 180 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K182503: Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (2019), 1 descendant of its own
- K203231: Switched Internal Paddles (2021), 0 descendants of its own

## Recalls of this device
- Jan 29, 2008 · Not classified · Z-2035-2008: Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately an

Source page: https://510kreport.com/device/K895379
Methodology: https://510kreport.com/methodology