510(k) · Cleared
ClearedNihon Kohden Tec-6100A Cardiolife Mini Defibrillator & 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 9, 1997 as substantially equivalent to K863404 (Nihon Kohden America, Inc., 1986) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 9, 1997
- Review
- 99 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863404 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863404 Cardiolife Tec 7100Nihon Kohden America, Inc. · 1986
- This deviceK971194 Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & AccessoriesNihon Kohden America, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863404 | Cardiolife Tec 7100 | Nihon Kohden America, Inc. | 1986 | — |
| 0 (this device) | K971194 | Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & Accessories | Nihon Kohden America, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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? (2)
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 |
|---|---|---|---|
| * | K863404 | Cardiolife Tec 7100Summary page 1…ce include Low-energy DC-defibrillator and Cardiac Monitor. The predicate marketed devices are the Nihon Kohden cardiolife, TEC-7100A Portable Defibrillator per 510(k) #K863404, commercial distribution certification dated October 31, 1986 and the Nihon Kohden cardiolife, TEC-8250A Portable Defibrillator p… | 1986 |
| * | K914971 | Tec-8251A Defibrillator Monitor, ModificationSummary page 1…brillator per 510(k) #K863404, commercial distribution certification dated October 31, 1986 and the Nihon Kohden cardiolife, TEC-8250A Portable Defibrillator per 510(k) #K914971, commercial distribution dated December 3, 1991. Nihon Kohden'’s cardiolife, model number TEC-6100A, is intended for medical pur… | 1991 |
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 2 ancestors has a recall.
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 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.
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/K971194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971194: Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971194
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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