510(k) · Cleared
ClearedAmplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LJE Catheter, Nephrostomy
Cleared on Jan 10, 2018 as substantially equivalent to K024050 (Cook Urological, Inc., 2003) after a 107-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Jan 10, 2018
- Review
- 107 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024050 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK024050 Cook Nephrostomy Dilation Balloon Catheter SetCook Urological, Inc. · 2003 · Recalled
- This deviceK172929 Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear…Boston Scientific Corporation · 2018
- Descendant · cites it directly · 0 of its ownK213334 Monarch Platform, UrologyAuris Health, Inc. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K213334Monarch Platform, UrologyAuris Health, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024050 | Cook Nephrostomy Dilation Balloon Catheter Set | Cook Urological, Inc. | 2003 | 2 |
| 0 (this device) | K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal… | Boston Scientific Corporation | 2018 | — |
| +1 | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 LJE? 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 LJE device
- #1 K250448 Disposable Percutaneous Nephrostomy Dilatation…score 9.9 · 2 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 |
|---|---|---|---|
| * | K024050 | Cook Nephrostomy Dilation Balloon Catheter SetSummary page 4…alloon Set Common/usual name: Catheter, Nephrostomy Classification Name: LJE – Catheter, Nephrostomy Premarket Notification: K024050, February 27, 2003 Ultraxx™ Nephrostomy Balloon Set (formerly Cook Nephrostomy Balloon Dilation Catheter Set, Coo… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213334 | Monarch Platform, Urology | 2022 | 0 |
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?
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJE
254in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJE
59in 2025
MAUDE reports naming product code LJE, 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 | 1 | — | 1 | 5 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 26 |
| 2017 | 1 | — | 0 | 60 |
| 2018 | 3 | 107 | 0 | 69 |
| 2019 | 4 | 254 | 1 | 78 |
| 2020 | 2 | — | 2 | 50 |
| 2021 | 0 | — | 1 | 38 |
| 2022 | 1 | — | 0 | 42 |
| 2023 | 1 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 47 |
| 2025 | 1 | — | 1 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.
The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access.
The Clear Renal Sheath is recommended for the establishment of percutaneous access.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172929: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172929
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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