510(k) · Cleared
ClearedTemporary Transvenous Pacemaker Placement Assist Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peter M. Rothenberg, M.D. · LDF Electrode, Pacemaker, Temporary
Cleared on Nov 20, 2003 after an 87-day review. The FDA summary names no predicate by number. 6 of the 37 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Nov 20, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 2 citing it directly. 6 of the 37 devices in this family, counting this one, have a Class I recall.
- This deviceK032613 Temporary Transvenous Pacemaker Placement Assist DevicePeter M. Rothenberg, M.D. · 2003
- Descendant · cites it directly · 34 of its ownK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- Descendant · 2 generations on · 13 of its ownK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- Descendant · 2 generations on · 10 of its ownK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 8 of its ownK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet3 generations on · 2012
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet3 generations on · 2013
- K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet4 generations on · 2013
- K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…4 generations on · 2016
Most influential descendants
Showing 5 of 36 · See all- K093775Evguide Tip Location SystemRomedex International Srl · 2010 · cites it directly34descendants
- K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · 2 generations on13descendants
- K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · 2 generations on10descendants
- K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · 2 generations on8descendants
- K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032613 | Temporary Transvenous Pacemaker Placement Assist Device | Peter M. Rothenberg, M.D. | 2003 | — |
| +1 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| +2 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| +2 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 4 |
| +2 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| +2 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 4 | 2 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 3 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
6 devices in this family have a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (36)
See all 362 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K093775 (Romedex International Srl, 2010) has gone furthest, with 34 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.
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?
This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind, and designed to isolate the proximal electrode from inadvertent stimulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032613: Temporary Transvenous Pacemaker Placement Assist Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032613
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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