510(k) · Cleared
ClearedMozec - RX Ptca Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meril Life Sciences Private Limited · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Dec 24, 2013 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) and 2 other predicates after a 244-day review. Its family tree reaches back 3 generations to 1980. 2 later devices descend from it.
- Decided
- Dec 24, 2013
- Review
- 244 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to P790017 (1980). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 2 generations backK103095 Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010
- 1 generation backK112735 Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd. · 2012
- This deviceK131169 Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013
- Descendant · cites it directly · 1 of its ownK160961 Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016
- Descendant · cites it directly · 0 of its ownK181023 Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA…Meril Life Sciences Private Limited · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −2 | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon | Medtronic, Ireland | 2010 | — |
| −1 | K112735 | Tamarin Blue Ptca RX Dilatation Catheter | Natec Medical, Ltd. | 2012 | — |
| 0 (this device) | K131169 | Mozec - RX Ptca Balloon Dilatation Catheter | Meril Life Sciences Private Limited | 2013 | — |
| +1 | K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016 | — |
| +1 | K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon… | Meril Life Sciences Private Limited | 2018 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | P790017 | Usci Dilatation CatheterSummary page 2…LOX Device Class: Class HI 5.5 Predicate device: 1. Sprinter Legend - Rx PTCA Balloon Dilatation Catheter (P790017) 2. Apex Monorail Balloon Catheter (P860019) 3. Taniarin blue® PTCA lix Dilatation Catheter (1(112735)… | 1980 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 2…Class HI 5.5 Predicate device: 1. Sprinter Legend - Rx PTCA Balloon Dilatation Catheter (P790017) 2. Apex Monorail Balloon Catheter (P860019) 3. Taniarin blue® PTCA lix Dilatation Catheter (1(112735) 5.6 Device description: MozeCTM _ Rx… | 1986 |
| * | K112735 | Tamarin Blue Ptca RX Dilatation CatheterSummary page 2…Legend - Rx PTCA Balloon Dilatation Catheter (P790017) 2. Apex Monorail Balloon Catheter (P860019) 3. Taniarin blue® PTCA lix Dilatation Catheter (1(112735) 5.6 Device description: MozeCTM _ Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid… | 2012 |
What descends from it? (2)
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 33 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K160961 (Meril Life Sciences Private Limited, 2016) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate P790017.
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. 2013, 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 Mozec TM - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec TM - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131169: Mozec - RX Ptca Balloon 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/K131169
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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