510(k) · Cleared
ClearedReprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · NLI Catheter, Angiography, Reprocessed
Cleared on Jul 1, 2024 as substantially equivalent to K915836 (Cordis Corp., 1992) and 1 other predicate after a 448-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jul 1, 2024
- Review
- 448 days
- Class
- Class II
- Product code
- NLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914007 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914007 Cordis 5.2 French Super Torque Plus Cardio CathCordis Corp. · 1991
- This deviceK231015 Reprocessed Super Torque and Super Torque Plus Diagnostic…Innovative Health, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914007 | Cordis 5.2 French Super Torque Plus Cardio Cath | Cordis Corp. | 1991 | — |
| 0 (this device) | K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Innovative Health, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 NLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K915836 | Cordis 5.0 French Super Torque CathetersSummary page 5…Product Code: NLI Predicate Device: 510(k) Number Device Manufacturer K915836 Cordis 5.0 French Super Torque Catheters Cordis Corp. K914007 Cordis 5.2 French Supe… | 1992 |
| * | K914007 | Cordis 5.2 French Super Torque Plus Cardio CathSummary page 5…r Device Manufacturer K915836 Cordis 5.0 French Super Torque Catheters Cordis Corp. K914007 Cordis 5.2 French Super Torque Plus Cordis Corp. Device Description: The reprocessed C… | 1991 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All NLI devicesNLI Catheter, Angiography, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NLI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NLI
Too few NLI 510(k)s in any year since 2007 to give a median.
Recalls per year · NLI
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLI
1in 2014
MAUDE reports naming product code NLI, 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 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231015: Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231015
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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