# K971355: Nihon Kohden Tec-7531 Cardiolife Portable Defibrillator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jul 15, 1997 after 95 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- 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.

## Cited in the summary but kept off the family tree
- K913085: Nihon Kohden cardiolife, TEC-8251A Portable Defibrillator. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
Nihon Kohden’s TEC-7531A cardiolife 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 electrical shock is delivered through paddles attached to the main unit. This device will supply a periodic electrical pulse intended to pace the heart when applied to the chest surface through electrodes. This device serves 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 lower limits. This device will also condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to its original format when received from another device, e.g. transmitter. The TEC-7531A 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/K971355
Methodology: https://510kreport.com/methodology