510(k) · Cleared
ClearedBantam Catheter (280MM Balloon Lengths)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearStream Technologies, Ltd. · DQY Catheter, Percutaneous
Cleared on Oct 12, 2011 as substantially equivalent to K093139 (ClearStream Technologies, Ltd., 2009) after a 61-day review. Its family tree reaches back 3 generations to 2004. 5 later devices descend from it.
- Decided
- Oct 12, 2011
- Review
- 61 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042537 (2004). 5 later devices descend from it, 1 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 deviceK112335 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 · 2 generations on · 1 of its ownK173621 Advocate PTA CatheterMerit Medical Systems, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK192907 Advocate PTA CatheterMerit Medical Systems, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K151153Pirouette 018Arravasc Limited · 2015 · cites it directly4descendants
- K162316Pirouette 014Arravasc, Ltd. · 2016 · 2 generations on2descendants
- K161427Pirouette 035Arravasc Limited · 2016 · 2 generations on2descendants
- K173621Advocate PTA CatheterMerit Medical Systems, Inc. · 2017 · 2 generations on1descendant
- K192907Advocate PTA CatheterMerit Medical Systems, Inc. · 2019 · 3 generations on0descendants
View 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) | 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 | — |
| +2 | K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017 | — |
| +3 | K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 2…re not designed to be used in the coronary arteries. Substantially Equivalent Devices The following devices are substantially equivalent predicate devices: * Bantam K093139 Comparison to predicate device The predicate device is the same as the Bantam (280mm balloon lengths) in material composition, d… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151153 | Pirouette 018 | 2015 | 4 |
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 7 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, K151153 (Arravasc Limited, 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K093139.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
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/K112335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112335: Bantam Catheter (280MM Balloon Lengths).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112335
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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