510(k) · Cleared
ClearedSABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis US Corp · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Aug 22, 2022 as substantially equivalent to K102035 (ClearStream Technologies, Ltd., 2010) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Aug 22, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K042537 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 3 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 2 generations backK093139 Bantam,48XXXXXX, 50XXXXXXClearStream Technologies, Ltd. · 2009
- 1 generation backK102035 Sleek Otw Pta CathetersClearStream Technologies, Ltd. · 2010
- This deviceK221832 SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation…Cordis US Corp · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −3 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −2 | K093139 | Bantam,48XXXXXX, 50XXXXXX | ClearStream Technologies, Ltd. | 2009 | — |
| −1 | K102035 | Sleek Otw Pta Catheters | ClearStream Technologies, Ltd. | 2010 | — |
| 0 (this device) | K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | 2022 | — |
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 |
|---|---|---|---|
| * | K102035 | Sleek Otw Pta CathetersSummary page 4…Name: Percutaneous Catheter (21 CFR 870.1250), Class II Product Code: LIT III. PREDICATE DEVICES SLEEK® OTW PTA Balloon Dilatation Catheter cleared on 12/01/2010 under K102035 and SLEEK® PTA Balloon Dilatation Catheter cleared on 02/08/2008 under K072947. Additional Reference Devices NANOCROSS™ ELITE OTW… | 2010 |
| * | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersSummary page 4…. PREDICATE DEVICES SLEEK® OTW PTA Balloon Dilatation Catheter cleared on 12/01/2010 under K102035 and SLEEK® PTA Balloon Dilatation Catheter cleared on 02/08/2008 under K072947. Additional Reference Devices NANOCROSS™ ELITE OTW PTA Dilatation Catheter .014 cleared on 7/18/201 under K141118 RAPIDCROSS™ PTA… | 2008 |
| † | K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter | 2014 |
| † | K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | 2013 |
| † | K131199 | Ultraverse RX Pta Balloon Dilatation Catheter | 2013 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K102035.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SABERTM .014 and SABERXTM .014 PTA Dilatation Catheters are intended to dilate stenoses in the peripheral vasculature, including femoral, popliteal and infra popliteal arteries. The device is also indicated for postdilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221832: SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221832
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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