510(k) · Cleared
ClearedReeflex Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearStream Technologies, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Aug 4, 2010 as substantially equivalent to K083596 (ClearStream Technologies, Ltd., 2009) after an 82-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Aug 4, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042537 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 2 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 1 generation backK083596 Reekross Family or Otw Pta CathetersClearStream Technologies, Ltd. · 2009
- This deviceK101361 Reeflex Pta CatheterClearStream Technologies, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −2 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −1 | K083596 | Reekross Family or Otw Pta Catheters | ClearStream Technologies, Ltd. | 2009 | — |
| 0 (this device) | K101361 | Reeflex Pta Catheter | ClearStream Technologies, Ltd. | 2010 | — |
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? (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 |
|---|---|---|---|
| * | K083596 | Reekross Family or Otw Pta CathetersSummary page 1…: 21 CFR 870.1250 Panel: Cardiovascular Product Code: LIT Predicate Device Information: Device Name: ReeKross Manufacturer: ClearStream Technologies Ltd Reference: K083 596 jKlb/3 lo 0 r2 6 2L… | 2009 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Balloon dilatation of the femoral, popliteal and infira popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101361: Reeflex Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101361
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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