510(k) · Cleared
ClearedLimFlow ARC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LimFlow, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on May 31, 2025 as substantially equivalent to K221541 (LimFlow, Inc., 2022) after a 29-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- May 31, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001577 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK001577 Outback CatheterLumend, Inc. · 2001 · Recalled
- 7 generations backK014117 Modification to Outback CatheterLumend, Inc. · 2002 · Recalled
- 6 generations backK032298 Modification to Outback CatheterLumend, Inc. · 2003 · Recalled
- 5 generations backK040771 Modification to Outback CatheterLumend, Inc. · 2004 · Recalled
- 4 generations backK043534 Modification to Outback CatheterLumend, Inc. · 2005 · Recalled
- 3 generations backK083814 Outback LTD RE-Entry Catheter, Model: OTB42120Cordis Corp., A Johnson & Johnson Co. · 2009
- 2 generations backK150836 OUTBACK Elite Re-Entry CatheterCordis Corporation, A Johnson & Johnson Co. · 2015
- 1 generation backK221541 LimFlow ARCLimFlow, Inc. · 2022
- This deviceK251376 LimFlow ARCLimFlow, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001577 | Outback Catheter | Lumend, Inc. | 2001 | 1 |
| −7 | K014117 | Modification to Outback Catheter | Lumend, Inc. | 2002 | 1 |
| −6 | K032298 | Modification to Outback Catheter | Lumend, Inc. | 2003 | 2 |
| −5 | K040771 | Modification to Outback Catheter | Lumend, Inc. | 2004 | 1 |
| −4 | K043534 | Modification to Outback Catheter | Lumend, Inc. | 2005 | 1 |
| −3 | K083814 | Outback LTD RE-Entry Catheter, Model: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009 | — |
| −2 | K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015 | — |
| −1 | K221541 | LimFlow ARC | LimFlow, Inc. | 2022 | — |
| 0 (this device) | K251376 | LimFlow ARC | LimFlow, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K221541 | LimFlow ARCSummary page 5…Percutaneous catheter Classification number 21 CFR 870.1250 Product code PDU Regulatory class II Predicate device LimFlow ARC (K221541) Description The LimFlow ARC is a single-use device designed to facilitate placement and… | 2022 |
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 24 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 8 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. 2025, 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 LimFlow ARC is intended to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251376: LimFlow ARC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251376
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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