510(k) · Cleared
Recalled · Class I · 2025Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Nov 15, 2024 as substantially equivalent to K101345 (Biosense Webster, Inc., 2010) and 1 other predicate after a 197-day review. Its family tree reaches back 8 generations to 1999. 1 of the 21 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Nov 15, 2024
- Review
- 197 days
- Class
- Class II
- Product code
- NLH
- Recalls
- 2 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 8 generations to K983171 (1999). 20 ancestors in all, the oldest K841802 (1984). No later device cites it as a predicate yet. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 7 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 6 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 5 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 4 generations backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- 3 generations backK123837 Pentaray Nav Eco High-Density Mapping CatheterBiosense Webster, Inc. · 2013 · Recalled
- 2 generations backK201750 Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc. · 2020
- 1 generation backK231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping…Biosense Webster, Inc. · 2023
- This deviceK241224 Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −7 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −6 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −5 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| −4 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| −3 | K123837 | Pentaray Nav Eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2013 | 5 |
| −2 | K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020 | — |
| −1 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… | Biosense Webster, Inc. | 2023 | — |
| 0 (this device) | K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer… | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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.
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 NLH device
- #1 K252405 Medline ReNewal Reprocessed Boston Scientific…score 10.4 · 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? (2)
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 |
|---|---|---|---|
| * | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer…Summary page 6…e models in this submission are the same as in the selection rationale predicate only that have been reprocessed 510(k) Number K101345 Biosense Webster Webster CS Catheter With EZ Proprietary or… | 2010 |
| * | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Summary page 6…se Webster, 510(k) applicant 333 Diamond Canyon Rd. Diamond Bar, CA 91765 510(k) Number K231312 PENTARAY NAV ECO High Density Mapping Catheter, DEC… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2025 | Class I | Z-1319-2026 | Under Investigation by firm | These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may… |
| Jul 31, 2025 | Class I | Z-2611-2025 | Under Investigation by firm | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 20 ancestors have a recall of any class.
- 8 other devices also cite its predicate K101345.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NLH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLH
165in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLH
28so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NLH
66in 2025
MAUDE reports naming product code NLH, 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 | 1 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 120 | 0 | 8 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 6 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 11 | 133 | 3 | 25 |
| 2017 | 4 | 138 | 0 | 11 |
| 2018 | 4 | 122 | 4 | 21 |
| 2019 | 4 | 195 | 0 | 38 |
| 2020 | 2 | — | 0 | 28 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 30 |
| 2024 | 6 | 165 | 0 | 47 |
| 2025 | 2 | — | 0 | 66 |
| 2026 | 0 | — | 28 (1) | — |
What is it indicated for?
The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241224: Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241224
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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