510(k) · Cleared
ClearedKhelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CathRx, Ltd. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Feb 10, 2022 as substantially equivalent to K113213 (Biosense Webster, Inc., 2011) after a 283-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Feb 10, 2022
- Review
- 283 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002333 (2000). 6 ancestors in all, the oldest K954390 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
- 4 generations backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
- 3 generations backK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
- 2 generations backK093376 Lasso Nav CatheterBiosense Webster, Inc. · 2010
- 1 generation backK113213 Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter…Biosense Webster, Inc. · 2011 · Recalled
- This deviceK211327 Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…CathRx, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | 2 |
| −4 | K031161 | Variable Lasso 2515 Circular Mapping Catheter | Biosense Webster, Inc. | 2003 | 2 |
| −3 | K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02 | Biosense Webster, Inc. | 2009 | — |
| −2 | K093376 | Lasso Nav Catheter | Biosense Webster, Inc. | 2010 | — |
| −1 | K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From… | Biosense Webster, Inc. | 2011 | 1 |
| 0 (this device) | K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed… | CathRx, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.7 · 1 generation · 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 |
|---|---|---|---|
| * | K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Summary page 4…on Number: 21 CFR 870.1220 Product Code: DRF Predicate Device: 510(k) Number 510(k) Title Manufacturer K113213 Lasso NAV 2515 Variable Biosense Webster Table 5.1: Predicate Device CathRx… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113213.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording or stimulation of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211327: Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211327
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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