510(k) · Cleared
ClearedChandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · LDF Electrode, Pacemaker, Temporary
Cleared on Oct 15, 2015 as substantially equivalent to K813521 (American Edwards Laboratories, 1982) after a 30-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.
- Decided
- Oct 15, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813521 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK813521 Transluminal Bipolar Pacing ProbeAmerican Edwards Laboratories · 1982
- This deviceK152633 Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal…Edwards Lifesciences, LLC · 2015
- Descendant · cites it directly · 0 of its ownK233983 Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing…Edwards Lifesciences · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5)…Edwards Lifesciences · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813521 | Transluminal Bipolar Pacing Probe | American Edwards Laboratories | 1982 | — |
| 0 (this device) | K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar… | Edwards Lifesciences, LLC | 2015 | — |
| +1 | K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter… | Edwards Lifesciences | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 LDF? 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 LDF device
- #1 K241334 Semi-Floating Temporary Pacing Electrode…score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K813521 | Transluminal Bipolar Pacing ProbeSummary page 4…mporary Name 21 CFR 870.3680(a), Product Code LDF Regulation Class II Class/Product Code LDF Predicate Device(s) K813521 TransluminalTM BiPolar Pacing Probe (cleared March 15, 1982) The Chandler Transluminal V-Pacing Probe an… | 1982 |
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 |
|---|---|---|---|
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5)… | 2024 | 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?
- Its one ancestor has no recall.
- Of its descendants, K233983 (Edwards Lifesciences, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LDF
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LDF
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDF
1in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDF
139in 2025
MAUDE reports naming product code LDF, 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 | 25 |
| 2008 | 1 | — | 2 | 18 |
| 2009 | 0 | — | 2 | 44 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 1 | 35 |
| 2012 | 0 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 1 | — | 0 | 68 |
| 2015 | 2 | — | 0 | 81 |
| 2016 | 3 | 138 | 0 | 90 |
| 2017 | 1 | — | 0 | 79 |
| 2018 | 1 | — | 1 (1) | 91 |
| 2019 | 1 | — | 0 | 130 |
| 2020 | 0 | — | 0 | 83 |
| 2021 | 0 | — | 0 | 125 |
| 2022 | 0 | — | 0 | 117 |
| 2023 | 0 | — | 0 | 212 |
| 2024 | 1 | — | 0 | 190 |
| 2025 | 5 | 266 | 0 | 139 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Chandler Transluminal V-Pacing Probe is indicated for temporary emergency ventricular pacing when used with a Swan-Ganz Paceport or A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraventricular ECG detection (during placement).
The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary emergency atrial pacing or sequential A-V pacing when used with a Swan-Ganz A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraatrial ECG detection (during placement).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152633: Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152633
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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