510(k) · Cleared
ClearedPantheris System
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 Nov 16, 2021 as substantially equivalent to K181642 (Eximo Medical, Ltd., 2018) and 1 other predicate after a 139-day review. Its family tree reaches back 18 generations to 1989. 1 of the 92 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 16, 2021
- Review
- 139 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K890505 (1989). 91 ancestors in all, the oldest K861606 (1986). No later device cites it as a predicate yet. 1 of the 92 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 14 generations between
- 3 generations backK162326 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. · 2016
- 2 generations backK172236 Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS…Avinger, Inc. · 2017
- 1 generation backK173862 Pantheris SystemAvinger, Inc. · 2018
- This deviceK212047 Pantheris SystemAvinger, Inc. · 2021
Show all 18 generations
- Root · 18 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 17 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 16 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 15 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 14 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 13 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 12 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 11 generations backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- 10 generations backK111338 Wildcat CatheterAvinger, Inc. · 2011
- 9 generations backK122380 Ocelot SystemAvinger, Inc. · 2012
- 8 generations backK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- 7 generations backK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
- 6 generations backK152275 Pantheris SystemAvinger, Inc. · 2015
- 5 generations backK153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016
- 4 generations backK160827 Pantheris CatheterAvinger, Inc. · 2016
- 3 generations backK162326 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. · 2016
- 2 generations backK172236 Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS…Avinger, Inc. · 2017
- 1 generation backK173862 Pantheris SystemAvinger, Inc. · 2018
- This deviceK212047 Pantheris SystemAvinger, Inc. · 2021
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…10 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −17 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −16 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −15 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −14 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −13 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −12 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −11 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| −10 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| −9 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| −8 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| −7 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
| −6 | K152275 | Pantheris System | Avinger, Inc. | 2015 | — |
| −5 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016 | — |
| −4 | K160827 | Pantheris Catheter | Avinger, Inc. | 2016 | — |
| −3 | K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Avinger, Inc. | 2016 | — |
| −2 | K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console… | Avinger, Inc. | 2017 | — |
| −1 | K173862 | Pantheris System | Avinger, Inc. | 2018 | — |
| 0 (this device) | 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 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 1 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K181642 | B-Laser Atherectomy SystemSummary page 4…Predicate Device #1—Primary Predicate Device Trade Name B-Laser Atherectomy System Common Name B-Laser Premarket Notification K181642 Regulation Number and 21 CFR§870.4875, Intraluminal Artery Stripper Classification Name Product Code MC… | 2018 |
| * | K173862 | Pantheris SystemSummary page 5…dicate Device #2—Reference Predicate Device Trade Name Pantheris System Common Name Pantheris Catheter Premarket Notification K173862 Regulation Number and 21 CFR§870.4875, Intraluminal Artery Stripper Classification Name 21 CFR§892.1560, Imagin… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 10 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 91 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K181642.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212047: Pantheris System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212047
Report an extraction error
Are you the manufacturer?
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