# K971436: Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Oct 21, 1997 after 186 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 K863405 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863405: Cardiolife Tec 7200, Nihon Kohden America, Inc. (1986) Summary page 1.
- K914971: Tec-8251A Defibrillator Monitor, Modification, Nihon Kohden America, Inc. (1991) Summary page 1.
- K920154: BSM-8800A Bedside Monitor, Nihon Kohden America, Inc. (1992) Summary page 1.
- K914092: BSM-2100A Configured Patient Monitor, Nihon Kohden America, Inc. (1992) Summary page 1.

## Most influential descendants
- K160667: Anybattery C2 Rechargeable Battery (2017), 0 descendants of its own

## Indications for use
Nihon Kohden’s TEC-7511A cardiolife and TEC-7521A cardiolife defibrillators are intended for medical purposes. The devices 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 devices deliver the electrical shock through paddies attached to the main unit. These devices will serve as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the heart rate falls outside preset upper and-ower-timits-~The-devices will-also tondition @ physiological signattobe " " transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to the original format when received from another device, e.g. transmitter. The TEC-7511A cardiolife and TEC-7521A cardiolife will be available for use by a physician, or under the supervision of a physician, for adult and pediatric patients within a medical facility and in remote environment.

Source page: https://510kreport.com/device/K971436
Methodology: https://510kreport.com/methodology