510(k) · Cleared
ClearedClearPetra Suction-Evacuation Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Dec 9, 2020 as substantially equivalent to K161110 (Well Lead Medical Co., Ltd., 2016) after a 54-day review. Its family tree reaches back 6 generations to 1977.
- Decided
- Dec 9, 2020
- Review
- 54 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K770378 (1977). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
- 5 generations backK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
- 4 generations backK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
- 3 generations backK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
- 2 generations backK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
- 1 generation backK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- This deviceK203119 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K770378 | Laparoscope, Fiber Light, Palmer-Jacobs | Richard Wolf Medical Instruments Corp. | 1977 | — |
| −5 | K962256 | Galileo Hysteroscopes and Laparoscopes | Galileo Electro-Optics Corp. | 1996 | — |
| −4 | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00… | Asap Endoscopic Products GmbH | 2003 | — |
| −3 | K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | 2007 | — |
| −2 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | 1 |
| −1 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| 0 (this device) | K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K161110 | ClearPetra Suction-Evacuation SheathSummary page 4…e And Accessories, Flexible/Rigid FGA–Kit, Nephroscope Regulatory Class: Class II Predicate Device(s): K161110- ClearPetra Suction-Evacuation Sheath 2. Indications for use The ClearPetra Suction-Evacuation Sheath is used to establish a… | 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 43 years and passes through 6 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 5 other devices also cite its predicate K161110.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during endoscopic procedures.
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/K203119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203119: ClearPetra Suction-Evacuation Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203119
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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