510(k) · Cleared
ClearedPantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avinger, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Oct 18, 2016 as substantially equivalent to K160827 (Avinger, Inc., 2016) and 2 other predicates after a 60-day review. Its family tree reaches back 15 generations to 1989. 1 of the 72 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Oct 18, 2016
- Review
- 60 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K890505 (1989). 68 ancestors in all, the oldest K861606 (1986). 3 later devices descend from it, 1 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 11 generations between
- 3 generations backK152275 Pantheris SystemAvinger, Inc. · 2015
- 2 generations backK153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016
- 1 generation backK160827 Pantheris CatheterAvinger, Inc. · 2016
- This deviceK162326 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK172236 Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS…Avinger, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK173862 Pantheris SystemAvinger, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK212047 Pantheris SystemAvinger, Inc. · 2021
Show all 15 generations
- Root · 15 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 14 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 13 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 12 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 11 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 10 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 9 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 8 generations backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- 7 generations backK111338 Wildcat CatheterAvinger, Inc. · 2011
- 6 generations backK122380 Ocelot SystemAvinger, Inc. · 2012
- 5 generations backK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- 4 generations backK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
- 3 generations backK152275 Pantheris SystemAvinger, Inc. · 2015
- 2 generations backK153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016
- 1 generation backK160827 Pantheris CatheterAvinger, Inc. · 2016
- This deviceK162326 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. · 2016
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…7 generations back · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −14 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −13 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −12 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −11 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −10 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −9 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −8 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| −7 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| −6 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| −5 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| −4 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
| −3 | K152275 | Pantheris System | Avinger, Inc. | 2015 | — |
| −2 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016 | — |
| −1 | K160827 | Pantheris Catheter | Avinger, Inc. | 2016 | — |
| 0 (this device) | K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Avinger, Inc. | 2016 | — |
| +1 | K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console… | Avinger, Inc. | 2017 | — |
| +2 | K173862 | Pantheris System | Avinger, Inc. | 2018 | — |
| +3 | K212047 | Pantheris System | Avinger, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K160827 | Pantheris CatheterSummary page 5…K162326 PREDICATE DEVICES • Primary Predicate Device – Avinger Pantheris System (K160827), hereafter referred to as the current Pantheris System • Secondary Predicate Device – Avinger Pantheris System (K152275), he… | 2016 |
| * | K152275 | Pantheris SystemSummary page 5…Predicate Device – Avinger Pantheris System (K160827), hereafter referred to as the current Pantheris System • Secondary Predicate Device – Avinger Pantheris System (K152275), hereafter referred to as the initial Pantheris System • Secondary Predicate Device - Avinger Ocelot System (K140185), herea… | 2015 |
| * | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleSummary page 5…ry Predicate Device – Avinger Pantheris System (K152275), hereafter referred to as the initial Pantheris System • Secondary Predicate Device - Avinger Ocelot System (K140185), hereafter referred to as the Ocelot System DEVICE DESCRIPTION The current Pantheris System (K160827), listed as the primar… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox… | 2017 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 7 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 68 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172236 (Avinger, Inc., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.
The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162326: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162326
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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