# K132488: Zoll Code Writer

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Apr 3, 2014 after 238 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941811 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103473: Zoll Rescuenet Epcr Model Rescuenet Epcr, ZOLL Medical Corporation (2011) Summary page 6.

## Indications for use
Code Writer is intended for the collection, storage and display of patient data that is entered by a user (ACLS caregiver) or uploaded from a ZOLL RSeries dlefibrillator/ monitor. Code Writer is intended for use by qualified ACLS caregivers responding to cardiac arrest events in a hospital environment to document the care provided. Code Writer is indicated for use by health care providers whenever there is a need for generation of a record of patient data for cardiac arrest events in a hospital environment. Code Writer should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.

Source page: https://510kreport.com/device/K132488
Methodology: https://510kreport.com/methodology