510(k) · Cleared
ClearedHexapolar Electrode Balloon Flotation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J-Lloyd Medical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Apr 20, 1998 as substantially equivalent to K930069 (J-Lloyd Medical, Inc., 1994) after a 360-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 20, 1998
- Review
- 360 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930069 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK930069 Bipolar Balloon Pacing Catheter by J-LloydJ-Lloyd Medical, Inc. · 1994
- This deviceK971504 Hexapolar Electrode Balloon Flotation CatheterJ-Lloyd Medical, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930069 | Bipolar Balloon Pacing Catheter by J-Lloyd | J-Lloyd Medical, Inc. | 1994 | — |
| 0 (this device) | K971504 | Hexapolar Electrode Balloon Flotation Catheter | J-Lloyd Medical, Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K930069 | Bipolar Balloon Pacing Catheter by J-LloydSummary page 1…oduct; Hexapolar Electrode Balloon Flotation Catheter I. Predicate Device: ‘ The J-LLoyd Medical, Inc. Bipolar Balldon Pacing Catheter has been approved by FDA ( 510K #K930069. The function of this device is to provide emergency, temporary pacing. II. Description of New Device: The Hexapolar Electrode… | 1994 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K930069.
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.
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 Hexapolar Electrode Balloon Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following:
1. Temporary use in electrophysiology studies;
2. Intra-cardiac ECG; and
3. Electrical stimulation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971504: Hexapolar Electrode Balloon Flotation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971504
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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