510(k) · Cleared
ClearedAmplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LJE Catheter, Nephrostomy
Cleared on Oct 19, 2017 as substantially equivalent to K851144 (Van-Tec, Inc., 1985) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.
- Decided
- Oct 19, 2017
- Review
- 59 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820865 (1982). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
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 | K820865 | Van-Tec Fascial Dilator | Van-Tec, Inc. | 1982 | — |
| 0 (this device) | K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set… | Cook Incorporated | 2017 | — |
| +1 | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K851144 | Ureteral Dilation SetSummary page 9…tz Radiopaque TFE Sheath Gastroenterology/Urology Clear Amplatz Sheath with Radiopaque Stripe Predicate Devices: K851144: 8/10 Dilator/Sheath Set; Amplatz Type Renal Dilator Sheath; Amplatz Type Renal Sheath; Clear Renal Sheath (Van-Tec, Inc.… | 1985 |
| * | K820865 | Van-Tec Fascial DilatorSummary page 9…cate Devices: K851144: 8/10 Dilator/Sheath Set; Amplatz Type Renal Dilator Sheath; Amplatz Type Renal Sheath; Clear Renal Sheath (Van-Tec, Inc.) K820865: Amplatz Type Graduated Renal Dilator; Fascial Dilators (Van-Tec, Inc.)… | 1982 |
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. 2017, 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?
Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath. Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract. Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath. Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement…
Read the full statement (118 words)
Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath.
Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract.
Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath.
Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement of a sheath.
Amplatz Radiopaque TFE Sheath is intended to be used as a working channel to maintain a previously established nephrostomy tract.
Clear Amplatz Sheath with Radiopaque Stripe is intended to be used as a working channel to maintain a previously established nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172527: Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172527
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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