510(k) · Cleared
ClearedTec-8251A Defibrillator Monitor, Modification
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 Dec 4, 1991 after a 47-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 4, 1991
- Review
- 47 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK914971 Tec-8251A Defibrillator Monitor, ModificationNihon Kohden America, Inc. · 1991
- Descendant · cites it directly · 1 of its ownK971436 Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator…Nihon Kohden America, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK160667 Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK971194 Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & AccessoriesNihon Kohden America, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K971436Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator and AccessoriesNihon Kohden America, Inc. · 1997 · cites it directly1descendant
- K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017 · 2 generations on0descendants
- K971194Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & AccessoriesNihon Kohden America, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914971 | Tec-8251A Defibrillator Monitor, Modification | Nihon Kohden America, Inc. | 1991 | — |
| +1 | K971436 | Nihon Kohden Tec-7511A/Tec-7521A Cardiolife Portable Defibrillator and… | Nihon Kohden America, Inc. | 1997 | — |
| +2 | K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017 | — |
| +1 | K971194 | Nihon Kohden Tec-6100A Cardiolife Mini Defibrillator & Accessories | Nihon Kohden America, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K971436 (Nihon Kohden America, Inc., 1997) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K914971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914971: Tec-8251A Defibrillator Monitor, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914971
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026