510(k) · Cleared
ClearedNihon Kohden Tec-7531 Cardiolife Portable Defibrillator and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Jul 15, 1997 as substantially equivalent to K863405 (Nihon Kohden America, Inc., 1986) and 2 other predicates after a 95-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 15, 1997
- Review
- 95 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K863405 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863405 Cardiolife Tec 7200Nihon Kohden America, Inc. · 1986
- This deviceK971355 Nihon Kohden Tec-7531 Cardiolife Portable Defibrillator and…Nihon Kohden America, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863405 | Cardiolife Tec 7200 | Nihon Kohden America, Inc. | 1986 | — |
| 0 (this device) | K971355 | Nihon Kohden Tec-7531 Cardiolife Portable Defibrillator and Accessories | Nihon Kohden America, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863405 | Cardiolife Tec 7200Summary page 1…ceiver and Radiofrequency Physiological Signal Transmitter. The predicate marketed devices are the Nihon Kohden cardiolife, TEC-7200A Portabie Defibrillator per 510(k) #K863405, commercial distribution certification dated October 31, 1986, the Nihon Kohden cardiolife, TEC-8251A Portable Defibrillator per… | 1986 |
| 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…efibrillator per 510(k) #K863405, commercial distribution certification dated October 31, 1986, the Nihon Kohden cardiolife, TEC-8251A Portable Defibrillator per 510(k) #K913085, commercial distribution dated September 25, 1991, the Nihon Kohden Life Scope 14, BSM-8800A Bedside Monitor per 510(k) #K920154,… | |
| * | K920154 | BSM-8800A Bedside MonitorSummary page 1…8251A Portable Defibrillator per 510(k) #K913085, commercial distribution dated September 25, 1991, the Nihon Kohden Life Scope 14, BSM-8800A Bedside Monitor per 510(k) #K920154, commercial distribution dated December 18, 1992 and the Nihon Kohden Life Scope L, BSM-2101A Bedside Monitor per 510(k) #K914092… | 1992 |
| * | K914092 | BSM-2100A Configured Patient MonitorSummary page 1…, BSM-8800A Bedside Monitor per 510(k) #K920154, commercial distribution dated December 18, 1992 and the Nihon Kohden Life Scope L, BSM-2101A Bedside Monitor per 510(k) #K914092, commercial distribution dated May 28, 1992. Nihon Kohden's TEC-7531A cardiolife is intended for medical purposes. The device wi… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K863405.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (181 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971355: Nihon Kohden Tec-7531 Cardiolife Portable Defibrillator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971355
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026