510(k) · Cleared
ClearedDABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ra Medical Systems,Inc · PDU Catheter For Crossing Total Occlusions
Cleared on Jun 29, 2022 as substantially equivalent to K210664 (Ra Medical Systems,Inc, 2021) after a 124-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Jun 29, 2022
- Review
- 124 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K890505 (1989). 28 ancestors in all, the oldest K871011 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations between
- 3 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 2 generations backK170349 RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc · 2017 · Recalled
- 1 generation backK210664 DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter…Ra Medical Systems,Inc · 2021
- This deviceK220544 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA…Ra Medical Systems,Inc · 2022
Show all 9 generations
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 8 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 7 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 6 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 5 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 4 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 3 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 2 generations backK170349 RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc · 2017 · Recalled
- 1 generation backK210664 DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter…Ra Medical Systems,Inc · 2021
- This deviceK220544 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA…Ra Medical Systems,Inc · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −8 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −7 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −6 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −5 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −4 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −3 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −2 | K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | 2017 | 5 |
| −1 | K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | 2021 | — |
| 0 (this device) | K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model… | Ra Medical Systems,Inc | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Summary page 4…utaneous catheter) Device Code: PDU III Identification of Predicate Device DABRA Laser System (DABRA Laser Model RA-308 And DABRA Catheter Model 101) (K210664) Reference Device: CLIRPATH Excimer Laser Catheter (K040067) IV Device Description The Ra Medical Systems’ DABRA™ La… | 2021 |
| † | K040067 | Clirpath Excimer Laser Catheter | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 28 ancestors have a recall of any class.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DABRA Excimer Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220544: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220544
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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