510(k) · Cleared
ClearedTamarin Blue Ptca RX Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natec Medical, Ltd. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Nov 2, 2012 as substantially equivalent to P860019 (Scimed Life Systems, Inc., 1986) and 3 other predicates after a 409-day review. Its family tree reaches back 2 generations to 1980. 5 later devices descend from it.
- Decided
- Nov 2, 2012
- Review
- 409 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to P790017 (1980). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 1 generation backK103095 Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010
- This deviceK112735 Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK131169 Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013
- Descendant · 2 generations on · 1 of its ownK160961 Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016
- Descendant · cites it directly · 0 of its ownK210012 Tamarin Blue PTCA RX Dilatation CatheterNatec Medical, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK181023 Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA…Meril Life Sciences Private Limited · 2018
- Descendant · cites it directly · 0 of its ownK141933 Filao NC RX Ptca Dilatation CatheterNatec Medical, Ltd. · 2015
Most influential descendants
Showing 5 of 5 · See all- K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013 · cites it directly2descendants
- K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016 · 2 generations on1descendant
- K210012Tamarin Blue PTCA RX Dilatation CatheterNatec Medical, Ltd. · 2021 · cites it directly0descendants
- K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited · 2018 · 2 generations on0descendants
- K141933Filao NC RX Ptca Dilatation CatheterNatec Medical, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −1 | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon | Medtronic, Ireland | 2010 | — |
| 0 (this device) | K112735 | Tamarin Blue Ptca RX Dilatation Catheter | Natec Medical, Ltd. | 2012 | — |
| +1 | K131169 | Mozec - RX Ptca Balloon Dilatation Catheter | Meril Life Sciences Private Limited | 2013 | — |
| +2 | K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016 | — |
| +1 | K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical, Ltd. | 2021 | — |
| +2 | K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon… | Meril Life Sciences Private Limited | 2018 | — |
| +1 | K141933 | Filao NC RX Ptca Dilatation Catheter | Natec Medical, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 LOX? 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 LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 1…ransluminal coronary angioplasty, percutaneous 870.5100 LOX Class Il Legally Marketed Equivalent Devices: = Maverick 2 PTCA Catheter - Boston Scientific Corporation — P860019 = Sprinter Legend Rapid Exchange Balloon Dilatation Catheter — Medtronic Ireland - P790017 = Trek ™ RX Coronary Dilatation Cath… | 1986 |
| * | P790017 | Usci Dilatation CatheterSummary page 1…ivalent Devices: = Maverick 2 PTCA Catheter - Boston Scientific Corporation — P860019 = Sprinter Legend Rapid Exchange Balloon Dilatation Catheter — Medtronic Ireland - P790017 = Trek ™ RX Coronary Dilatation Catheter - Abbott Vascular Inc. — K103110 . DEVICE DESCRIPTION The Tamarin Blue® PTCA RX Dilat… | 1980 |
| * | K103110 | Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and…Summary page 1…— P860019 = Sprinter Legend Rapid Exchange Balloon Dilatation Catheter — Medtronic Ireland - P790017 = Trek ™ RX Coronary Dilatation Catheter - Abbott Vascular Inc. — K103110 . DEVICE DESCRIPTION The Tamarin Blue® PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a singl… | 2011 |
| * | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonSummary page 2…on Catheter uses similar technology, materials and methods of operation as the approved predicates: Maverick2 PTCA Catheter (P860019), Sprinter Legend RX (P790017/5096 & K103095) and Trek ™ RX device (K103110). The properties of the Tamarin Blue® PTCA RX Catheter to treat disease are identical to predicate… | 2010 |
What descends from it? (5)
3 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 32 years and passes through 2 companies; a new generation was cleared every 30.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K131169 (Meril Life Sciences Private Limited, 2013) has gone furthest, with 2 descendants of its own.
- 20 other devices also cite its predicate P860019.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, 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 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
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/K112735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112735: Tamarin Blue Ptca RX Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112735
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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