510(k) · Cleared
ClearedLifepak 9 Defibrillator/Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control Corp. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Dec 16, 1993 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 16, 1993
- Review
- 8 days
- Class
- Class II
- Product code
- LDD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK935674 Lifepak 9 Defibrillator/MonitorPhysio-Control Corp. · 1993
- Descendant · cites it directly · 1 of its ownK020701 Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002
- Descendant · 2 generations on · 0 of its ownK024071 Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003
- Descendant · cites it directly · 0 of its ownK982896 Alexander Manufacturing CO. Rechargeable Battery Part Number LP9Alexander Mfg. Co. · 1998
Most influential descendants
Showing 3 of 3 · See all- K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002 · cites it directly1descendant
- K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003 · 2 generations on0descendants
- K982896Alexander Manufacturing CO. Rechargeable Battery Part Number LP9Alexander Mfg. Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935674 | Lifepak 9 Defibrillator/Monitor | Physio-Control Corp. | 1993 | — |
| +1 | K020701 | Syncrus Internal Cardioversion System | Guidant Corporation, Cardiac Surgery | 2002 | — |
| +2 | K024071 | Guidant Syncrus Internal Cardioversion System | Guidant Corporation, Cardiac Surgery | 2003 | — |
| +1 | K982896 | Alexander Manufacturing CO. Rechargeable Battery Part Number LP9 | Alexander Mfg. Co. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 has not posted a summary or statement for it, 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, K020701 (Guidant Corporation, Cardiac Surgery, 2002) 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/K935674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935674: Lifepak 9 Defibrillator/Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935674
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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