510(k) · Cleared
ClearedCronus HP PTA Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Oct 24, 2019 as substantially equivalent to K151141 (Nipro Medical Corporation, 2016) after a 289-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Oct 24, 2019
- Review
- 289 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001134 (2000). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 7 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 6 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 5 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 4 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 3 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 2 generations backK110319 Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc. · 2011
- 1 generation backK151141 Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation · 2016
- This deviceK190037 Cronus HP PTA Balloon CatheterNipro Medical Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −7 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −6 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −5 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −4 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −3 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −2 | K110319 | Evercross 0.035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2011 | — |
| −1 | K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | Nipro Medical Corporation | 2016 | — |
| 0 (this device) | K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K151141 | Cronus HP - High Pressure Peripheral Balloon CatheterSummary page 4…ardiovascular Product Code: LIT 807.92(a)(3) Legally marketed substantial equivalent device: Cronus HP – High Pressure Peripheral Balloon Catheter (K151141) 807.92(a)(4) Description of device: The Cronus™ HP PTA Balloon Catheter is intended for PTA (Percutaneous Translu… | 2016 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 17 ancestors have a recall of any class.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Cronus HP PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the following vessel areas:
- Femoral arteries
- Popliteal arteries
- Iliac arteries
- Renal arteries
- For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
These catheters are not intended for use in coronary arteries or the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190037 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190037: Cronus HP PTA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190037
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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