510(k) · Cleared
ClearedNihon Kohden Tec-7511A/Tec-7521A 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 Oct 21, 1997 as substantially equivalent to K863405 (Nihon Kohden America, Inc., 1986) and 3 other predicates after a 186-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.
- Decided
- Oct 21, 1997
- Review
- 186 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K863405 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK863405 Cardiolife Tec 7200Nihon Kohden America, Inc. · 1986
- This deviceK971436 Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator…Nihon Kohden America, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK160667 Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017 · cites it directly0descendants
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) | K971436 | Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator and… | Nihon Kohden America, Inc. | 1997 | — |
| +1 | K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863405 | Cardiolife Tec 7200Summary page 1…Signal Receiver and Radiofrequency Physiological Signal Transmitter. The predicate devices are the Nihon Kohden TEC-7200A cardiolife Portabie Defibrillator per 510(k) #K863405, commercial distribution certification dated October 31, 1986, the Nihon Kohden TEC-8250A cardiolife Portable Defibrillator per 5… | 1986 |
| * | K914971 | Tec-8251A Defibrillator Monitor, ModificationSummary page 1…Defibrillator per 510(k) #K863405, commercial distribution certification dated October 31, 1986, the Nihon Kohden TEC-8250A cardiolife Portable Defibrillator per 510(k) #K914971, commercial distribution certification dated December 3, 1991, the Nihon Kohden BSM-8800A Life Scope 14 Bedside Monitor, per 510(… | 1991 |
| * | K920154 | BSM-8800A Bedside MonitorSummary page 1…le Defibrillator per 510(k) #K914971, commercial distribution certification dated December 3, 1991, the Nihon Kohden BSM-8800A Life Scope 14 Bedside Monitor, per 510(k) #K920154, commercial distributicn certification dated December 18, 1992 and the Nihon Kohden BSM-2101A Life Scope L Bedside Monitor per 51… | 1992 |
| * | K914092 | BSM-2100A Configured Patient MonitorSummary page 1…dside Monitor, per 510(k) #K920154, commercial distributicn certification dated December 18, 1992 and the Nihon Kohden BSM-2101A Life Scope L Bedside Monitor per 510(k) #K914092, commercial distribution certification dated May 28, 1992. Nihon Kohden's TEC-7511A and TEC-7521A cardiolife defibriflators are… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160667 | Anybattery C2 Rechargeable Battery | 2017 | 0 |
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?
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-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…
Read the full statement (161 words)
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.
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/K971436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971436: Nihon Kohden Tec-7511A/Tec-7521A 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/K971436
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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