510(k) · Cleared
Recalled · Class II · 2024Chameleon PTA Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Av Medical Technologies, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jan 17, 2017 as substantially equivalent to K151678 (Av Medical Technologies, Ltd., 2015) and 1 other predicate after a 61-day review. Its family tree reaches back 6 generations to 2002. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 17, 2017
- Review
- 61 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K014212 (2002). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK014212 Bard Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2002
- 5 generations backK073472 Vaccess Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- 4 generations backK101047 Pta-Duo Pta Balloon CatheterHotspur Technologies · 2010
- 3 generations backK113769 Gpscath Ballon Dilatation CatheterHotspur Technologies · 2012
- 2 generations backK130397 Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies · 2013
- 1 generation backK151678 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2015
- This deviceK163231 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK170635 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K014212 | Bard Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2002 | — |
| −5 | K073472 | Vaccess Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 1 |
| −4 | K101047 | Pta-Duo Pta Balloon Catheter | Hotspur Technologies | 2010 | — |
| −3 | K113769 | Gpscath Ballon Dilatation Catheter | Hotspur Technologies | 2012 | — |
| −2 | K130397 | Arrow Gpscath Balloon Dilatation Catheter | Hotspur Technologies | 2013 | — |
| −1 | K151678 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2015 | — |
| 0 (this device) | K163231 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | — |
| +1 | K170635 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K151678 | Chameleon PTA Balloon CatheterSummary page 4…ous Catheter (LIT) 21 CFR 870.1210, Continuous Flush Catheter (KRA) 8. Predicate Device(s): AV Medical Technologies Ltd., Chameleon PTA Balloon Catheter, K151678 Micro Medical Solutions, Inc., MMS Guide Catheter, K152625 9. Device Description: The Chameleon Percutaneous Tran… | 2015 |
| * | K152625 | MMS Guide CatheterSummary page 4…er (KRA) 8. Predicate Device(s): AV Medical Technologies Ltd., Chameleon PTA Balloon Catheter, K151678 Micro Medical Solutions, Inc., MMS Guide Catheter, K152625 9. Device Description: The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170635 | Chameleon PTA Balloon Catheter | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2024 | Class II | Z-0257-2025 | Under Investigation by firm | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. |
| Dec 17, 2021 | Class II | Z-0557-2022 | Under Investigation by firm | The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K170635 (Av Medical Technologies, Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163231: Chameleon PTA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163231
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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