# K971194: Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jul 9, 1997 after 99 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- 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 K863404 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863404: Cardiolife Tec 7100, Nihon Kohden America, Inc. (1986) Summary page 1.
- K914971: Tec-8251A Defibrillator Monitor, Modification, Nihon Kohden America, Inc. (1991) Summary page 1.

## Indications for use
Nihon Kohden’s cardiolife, model number TEC-6100A4, is intended for medical purposes. The device will deliver an electrical shock of a maximum of 360 Joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device also serves as a cardiac monitor, with the ability to measure heart rate. The TEC-6100A will be available for use by a physician or under the supervision of a phys1c1an within a medical facility and-tn-sesmntrenviseament. This device is not intended for use in ambulances. The device is intended for use with adult and pediatric patients.

Source page: https://510kreport.com/device/K971194
Methodology: https://510kreport.com/methodology