510(k) · Cleared
ClearedSleek Otw Pta Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearStream Technologies, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 1, 2010 as substantially equivalent to K093139 (ClearStream Technologies, Ltd., 2009) after a 135-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Dec 1, 2010
- Review
- 135 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042537 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 2 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 1 generation backK093139 Bantam,48XXXXXX, 50XXXXXXClearStream Technologies, Ltd. · 2009
- This deviceK102035 Sleek Otw Pta CathetersClearStream Technologies, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK221832 SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation…Cordis US Corp · 2022
- Descendant · cites it directly · 0 of its ownK130786 Sleek Otw Pta CatheterC.R. Bard, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −2 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −1 | K093139 | Bantam,48XXXXXX, 50XXXXXX | ClearStream Technologies, Ltd. | 2009 | — |
| 0 (this device) | K102035 | Sleek Otw Pta Catheters | ClearStream Technologies, Ltd. | 2010 | — |
| +1 | K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | 2022 | — |
| +1 | K130786 | Sleek Otw Pta Catheter | C.R. Bard, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · 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 |
|---|---|---|---|
| * | K093139 | Bantam,48XXXXXX, 50XXXXXXSummary page 1…870.1250 Product Code: LIT Predicate Device: ClearStream Technologies Ltd, proposes its Bantam a PTA Catheter cleared through the following 510(k) number submission: K093139, as the predicate device for this submission. Device Description: The Sleek OTW PTA Catheter is a standard over-the-wire PTA c… | 2009 |
| † | K100490 | Litepac, Model 682 | 2010 |
| † | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221832 (Cordis US Corp, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K093139.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
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/K102035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102035: Sleek Otw Pta Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102035
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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