510(k) · Cleared
Recalled · Class II · 2014Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creganna-Tactx Medical · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jun 10, 2011 as substantially equivalent to P880003 (Cordis Corp., 1988) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1986. 10 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 10, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to P860019 (1986). 2 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 1 generation backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- This deviceK110133 Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation…Creganna-Tactx Medical · 2011
- Descendant · cites it directly · 6 of its ownK111544 Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK121681 Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK133633 Chocolate Ptca Bolloon CatheterTrireme Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK150292 Chocolate PTCA Balloon CatheterTrireme Medical, LLC · 2015
- Descendant · cites it directly · 1 of its ownK160961 Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K111544Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012 · cites it directly6descendants
- K121681Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012 · cites it directly4descendants
- K133633Chocolate Ptca Bolloon CatheterTrireme Medical, Inc. · 2014 · 2 generations on3descendants
- K150292Chocolate PTCA Balloon CatheterTrireme Medical, LLC · 2015 · 2 generations on2descendants
- K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| 0 (this device) | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | Creganna-Tactx Medical | 2011 | — |
| +1 | K111544 | Glider Ptca Balloon Catheter | Trireme Medical, Inc. | 2012 | — |
| +1 | K121681 | Glider Ptca Balloon Catheter | Trireme Medical, Inc. | 2012 | — |
| +2 | K133633 | Chocolate Ptca Bolloon Catheter | Trireme Medical, Inc. | 2014 | — |
| +2 | K150292 | Chocolate PTCA Balloon Catheter | Trireme Medical, LLC | 2015 | — |
| +1 | K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | P880003 | Cordis Ptca Dilatation CatheterSummary page 1…N K rffaY; 1 W00 9100 1 OT a i on Ufhtew Standard PTCA Catheter 21 CFR 870.5 100 Cordis Fire Star P880003 Boston Scientific's Maverick 2 Monorail P860019 Standard PTCA Catheter 21 CFR 870.5 100… | 1988 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 1…T a i on Ufhtew Standard PTCA Catheter 21 CFR 870.5 100 Cordis Fire Star P880003 Boston Scientific's Maverick 2 Monorail P860019 Standard PTCA Catheter 21 CFR 870.5 100 Cordis Dura Star… | 1986 |
What descends from it? (10)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2014 | Class II | Z-2556-2014 | Environmental control | The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to… |
| Jun 23, 2014 | Class II | Z-2557-2014 | Environmental control | The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to… |
| Feb 5, 2013 | Class II | Z-1784-2014 | Process design | Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2011, 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 EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110133 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca 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/K110133
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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