510(k) · Cleared
ClearedReef HP 0.035 Otw Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invatec S.P.A. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Oct 29, 2009 as substantially equivalent to K062809 (Invatec Innovative Technologies, 2006) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it.
- Decided
- Oct 29, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K042538 (2004). 3 ancestors in all, the oldest K032737 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK042538 Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 1 generation backK062809 Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006
- This deviceK092361 Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 2009
- Descendant · cites it directly · 1 of its ownK123358 Pacific PlusMedtronic Vascular · 2013
- Descendant · 2 generations on · 0 of its ownK202800 Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) · 2020
- Descendant · cites it directly · 0 of its ownK121265 Amphirion Plus Pta CatheterMedtronic, Inc. · 2012
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 |
|---|---|---|---|---|---|
| −2 | K042538 | Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −1 | K062809 | Admiral Xtreme Pta Catheter | Invatec Innovative Technologies | 2006 | — |
| 0 (this device) | K092361 | Reef HP 0.035 Otw Pta Balloon Dilatation Catheter | Invatec S.P.A. | 2009 | — |
| +1 | K123358 | Pacific Plus | Medtronic Vascular | 2013 | — |
| +2 | K202800 | Pacific Plus PTA Catheter | Medtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC) | 2020 | — |
| +1 | K121265 | Amphirion Plus Pta Catheter | Medtronic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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.
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? (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 |
|---|---|---|---|
| * | K062809 | Admiral Xtreme Pta CatheterSummary page 1…uminal Angioplasty Catheter Regulation Name: Percutaneous Catheter Predicate Devices * Invatec Admiral Extreme 0.035" OTW PTA Balloon Dilatation Catheter (K062809) * Cordis Powerflex Extreme PTA Balloon Catheter (K032737) Device Description The Reef HP 0.035"OTW PTA Balloon Catheter is… | 2006 |
| * | K032737 | Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon…Summary page 1…Catheter Predicate Devices * Invatec Admiral Extreme 0.035" OTW PTA Balloon Dilatation Catheter (K062809) * Cordis Powerflex Extreme PTA Balloon Catheter (K032737) Device Description The Reef HP 0.035"OTW PTA Balloon Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA)… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K123358 (Medtronic Vascular, 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K062809.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The REEF HP 0.035" OTW PTA Balloon Dilatation Catheters are intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092361 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092361: Reef HP 0.035 Otw Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092361
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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