510(k) · Cleared
ClearedNephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FGA Kit, Nephroscope
Cleared on Jun 5, 2000 as substantially equivalent to K770729 (Richard Wolf Medical Instruments Corp., 1977) after a 173-day review. Its family tree reaches back 1 generation to 1977. 1 of the 13 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Jun 5, 2000
- Review
- 173 days
- Class
- Class II
- Product code
- FGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K770729 (1977). 11 later devices descend from it, 3 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK770729 Pyeloscope SystemRichard Wolf Medical Instruments Corp. · 1977
- This deviceK994223 Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment…Richard Wolf Medical Instruments Corp. · 2000
- Descendant · cites it directly · 8 of its ownK151308 Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH · 2016
- Descendant · 2 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK243820 Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s…Dornier Medtech America · 2025
- Descendant · 3 generations on · 0 of its ownK261915 Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
- Descendant · 4 generations on · 0 of its ownK252572 Prodeon Urethral Sheath SystemProdeon Medical, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200770 Mini PCNL-Systemcites it directly · 2021
Most influential descendants
Showing 5 of 11 · See all- K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH · 2016 · cites it directly8descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 2 generations on7descendants
- K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America · 2025 · 3 generations on1descendant
- K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026 · 3 generations on0descendants
- K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770729 | Pyeloscope System | Richard Wolf Medical Instruments Corp. | 1977 | — |
| 0 (this device) | K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope… | Richard Wolf Medical Instruments Corp. | 2000 | — |
| +1 | K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Schoelly Fiberoptic GmbH | 2016 | — |
| +2 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +3 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040… | Dornier Medtech America | 2025 | — |
| +3 | K261915 | Navigator™ Flex Ureteral Access Sheath Set | Boston Scientific Corporation | 2026 | — |
| +4 | K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2025 | 4 | 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.
1 device in this family has a Class I recall. 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 FGA device
- #1 K232370 Percutaneous Nephroscope Systemscore 5.3 · 1 generation · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K770729 | Pyeloscope SystemSummary page 1…stantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer 1 pre-eanctment 1 Fiber Kight Operating Laparoscope 4937 1 Richard Wolf 2 K770729 2 Pylescope System 2 Richard Wolf 3 3 Operating Syet for Percutaneous Removal of 3 Karl Stoz Kidney Stones 27090 / 27092 / 27093… | 1977 |
| * | — | Fiber Light Operating Laparoscope 4937 Named without a submission number | |
| * | — | Operating System for Percutaneous Removal of Kidney Stones 27090 / 27092 / 27093 Named without a submission number | |
| * | — | Rigid Percutaneous Nephroscope MRO-20 Named without a submission number |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200770Mini PCNL-SystemTrokamed GmbH · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K151308 (Schoelly Fiberoptic GmbH, 2016) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FGA devicesFGA Kit, Nephroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FGA
Too few FGA 510(k)s in any year since 2007 to give a median.
Recalls per year · FGA
No recall names FGA since 2007.
Adverse event reports per year · FGA
36in 2025
MAUDE reports naming product code FGA, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The nephroscope, with its accessories, is used, with suction, for the disintegration and
removal / extraction of kidney and bladder stones. The stones are removed, under
endoscopic control, through percutaneous or transurethal passages, in conjuction with
intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotriptors.
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/K994223 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994223: Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994223
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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