510(k) · Cleared
ClearedElectrode Catheter, Orthogonal Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Webster Laboratories, Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Oct 18, 1984 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Oct 18, 1984
- Review
- 170 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceK841802 Electrode Catheter, Orthogonal TypeWebster Laboratories, Inc. · 1984
- Descendant · cites it directly · 7 of its ownK080425 CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK091780 Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK241224 Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK240826 Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed…Sterilmed, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…3 generations on · 2024
Most influential descendants
Showing 5 of 8 · See all- K080425CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc. · 2008 · cites it directly7descendants
- K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc. · 2023 · 2 generations on3descendants
- K091780Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009 · 2 generations on1descendant
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 3 generations on0descendants
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K841802 | Electrode Catheter, Orthogonal Type | Webster Laboratories, Inc. | 1984 | — |
| +1 | K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 | Biosense Webster, Inc. | 2008 | — |
| +2 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| +2 | K091780 | Guided Measurement Catheter (GMC) | Mediguide, Ltd. | 2009 | — |
| +3 | K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer… | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024 | Class I |
| +2 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER®… | Sterilmed, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 1 |
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.
1 device in this family has 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 | 2008 | 7 |
Has anything in its family been recalled? (1 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.
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K080425 (Biosense Webster, Inc., 2008) has gone furthest, with 7 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) | — |
https://510kreport.com/device/K841802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K841802: Electrode Catheter, Orthogonal Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841802
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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