510(k) · Cleared
ClearedBantam,48XXXXXX, 50XXXXXX
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 30, 2009 as substantially equivalent to K072947 (ClearStream Technologies, Ltd., 2008) after an 86-day review. Its family tree reaches back 2 generations to 2004. 9 later devices descend from it.
- Decided
- Dec 30, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042537 (2004). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 1 generation backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- This deviceK093139 Bantam,48XXXXXX, 50XXXXXXClearStream Technologies, Ltd. · 2009
- Descendant · cites it directly · 5 of its ownK112335 Bantam Catheter (280MM Balloon Lengths)ClearStream Technologies, Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
- Descendant · 2 generations on · 2 of its ownK162316 Pirouette 014Arravasc, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK161427 Pirouette 035Arravasc Limited · 2016
- Descendant · cites it directly · 2 of its ownK102035 Sleek Otw Pta CathetersClearStream Technologies, Ltd. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112335Bantam Catheter (280MM Balloon Lengths)ClearStream Technologies, Ltd. · 2011 · cites it directly5descendants
- K151153Pirouette 018Arravasc Limited · 2015 · cites it directly4descendants
- K162316Pirouette 014Arravasc, Ltd. · 2016 · 2 generations on2descendants
- K161427Pirouette 035Arravasc Limited · 2016 · 2 generations on2descendants
- K102035Sleek Otw Pta CathetersClearStream Technologies, Ltd. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −1 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| 0 (this device) | K093139 | Bantam,48XXXXXX, 50XXXXXX | ClearStream Technologies, Ltd. | 2009 | — |
| +1 | K112335 | Bantam Catheter (280MM Balloon Lengths) | ClearStream Technologies, Ltd. | 2011 | — |
| +1 | K151153 | Pirouette 018 | Arravasc Limited | 2015 | — |
| +2 | K162316 | Pirouette 014 | Arravasc, Ltd. | 2016 | — |
| +2 | K161427 | Pirouette 035 | Arravasc Limited | 2016 | — |
| +1 | K102035 | Sleek Otw Pta Catheters | ClearStream Technologies, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersSummary page 1…870.1250 Product Code: OQY Predicate Device: ClearStream Technologies Ltd, proposes its Savvy Long PTA Catheter cleared through the following 510(k) number submission: K072947, as the predicate device for this submission. Device Description: The Bantam and Bantam a PTA Catheters are standard over-the-w… | 2008 |
What descends from it? (9)
3 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 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112335 (ClearStream Technologies, Ltd., 2011) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K072947.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 as stated in the FDA summary.
https://510kreport.com/device/K093139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093139: Bantam,48XXXXXX, 50XXXXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093139
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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