510(k) · Cleared
Recalled · Class I · 2025Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on May 31, 2023 as substantially equivalent to K151622 (St Jude Medical, 2015) after a 414-day review. Its family tree reaches back 4 generations to 1993. 1 of the 13 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- May 31, 2023
- Review
- 414 days
- Class
- Class II
- Product code
- NLH
- Recalls
- 3 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913940 (1993). 12 ancestors in all, the oldest K894500 (1989). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK913940 Response (TM) Steerable CatheterDaig Corp. · 1993
- 3 generations backK102721 Livewire Electophysiology CatheterSt Jude Medical · 2010
- 2 generations backK150631 St. Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- 1 generation backK151622 St.Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- This deviceK221067 Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable…Surgical Instrument Service and Savings, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913940 | Response (TM) Steerable Catheter | Daig Corp. | 1993 | — |
| −3 | K102721 | Livewire Electophysiology Catheter | St Jude Medical | 2010 | — |
| −2 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology… | St Jude Medical | 2015 | — |
| −1 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology… | St Jude Medical | 2015 | — |
| 0 (this device) | K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable… | Surgical Instrument Service and Savings, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…Summary page 5…Regulatory Class 2 Product Code NLH Panel Cardiovascular 510(k) Number K151622 St. Jude Medical MediGuide Enabled Livewire Steer… | 2015 |
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-1321-2026 | 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-2610-2025 | 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… |
| Feb 6, 2025 | Class II | Z-1460-2025 | Under Investigation by firm | Devices may have higher than expected amounts of bacterial endotoxin. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 4 other devices also cite its predicate K151622.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221067: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221067
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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