510(k) · Cleared
ClearedLitepac, Model 682
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearStream Technologies, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Mar 16, 2010 as substantially equivalent to K072947 (ClearStream Technologies, Ltd., 2008) after a 25-day review. Its family tree reaches back 2 generations to 2004. 12 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 25 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042537 (2004). 12 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 1 generation backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- This deviceK100490 Litepac, Model 682ClearStream Technologies, Ltd. · 2010
- Descendant · cites it directly · 11 of its ownK131199 Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK150865 Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation · 2015
- Descendant · 2 generations on · 3 of its ownK180921 Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK152873 Crosstella RX Balloon Dilatation CatheterKANEKA Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK252295 RyureiTerumo Corporation · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013 · cites it directly11descendants
- K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation · 2015 · 2 generations on4descendants
- K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018 · 2 generations on3descendants
- K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation · 2016 · 3 generations on1descendant
- K252295RyureiTerumo Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −1 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| 0 (this device) | K100490 | Litepac, Model 682 | ClearStream Technologies, Ltd. | 2010 | — |
| +1 | K131199 | Ultraverse RX Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2013 | — |
| +2 | K150865 | Metacross RX PTA Balloon Dilitation Catheter | KANEKA Corporation | 2015 | — |
| +2 | K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| +3 | K152873 | Crosstella RX Balloon Dilatation Catheter | KANEKA Corporation | 2016 | — |
| +3 | K252295 | Ryurei | Terumo Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersSummary page 1…CFR 870.1250 Product Code: DQY Predicate Device: ClearStream Technologies Ltd,. proposes its Sleek PTA Catheter cleared through the following 510(k) number submission: K072947, as the predicate device for this submission. Device Description: The LitePAC PTA Catheter is a standard rapid exchange P… | 2008 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131199 | Ultraverse RX Pta Balloon Dilatation Catheter | 2013 | 11 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131199 (Bard Peripheral Vascular, Inc., 2013) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K072947.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100490 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100490: Litepac, Model 682.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100490
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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