510(k) · Cleared
Recalled · Class II · 2024Monarch Platform, Urology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auris Health, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Apr 29, 2022 as substantially equivalent to K153049 (Boston Scientific Corporation, 2015) and 4 other predicates after a 205-day review. Its family tree reaches back 8 generations to 1993. 1 of the 36 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Apr 29, 2022
- Review
- 205 days
- Class
- Class II
- Product code
- FGB
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 8 generations to K931154 (1993). 35 ancestors in all, the oldest K770729 (1977). No later device cites it as a predicate yet. 1 of the 36 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 4 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 3 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 2 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 1 generation backK153049 LithoVue SystemBoston Scientific Corporation · 2015
- This deviceK213334 Monarch Platform, UrologyAuris Health, Inc. · 2022
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope6 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −4 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −3 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −2 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −1 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 3 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K153049 | LithoVue SystemSummary page 5…ystem Device Classification Name: Ureteroscope and Accessories, Flexible/Rigid Regulation Description: Endoscope and Accessories 510(k) Number: K153049 Regulation Number: 876.1500 Device Class Class II Product Code: FGB Proprietary N… | 2015 |
| * | K162992 | Karl Storz UROMAT E.A.S.I.Summary page 5…E.A.S.I. Device Classification Name: System, Irrigation, Urological Regulation Description: Urological Catheter and Accessories 510(k) Number: K162992 Regulation Number: 876.5130 Device Class Class II Product Code: LJH Proprietary N… | 2017 |
| * | K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz…Summary page 6…Amplatz Renal Dilator Kit Device Classification Name: Catheter, Nephrostomy Regulation Description: Unclassified 510(k) Number: K172527 Regulation Number: None Device Class Class II Product Code: LJE Proprietary N… | 2017 |
| * | K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree…Summary page 6…Richard Wolf Nephroscope Set Device Classification Name: Kit, Nephroscope Regulation Description: Endoscope and accessories 510(k) Number: K994223 Regulation Number: 876.1500 Device Class Class II Product Code: FGA Proprieta… | 2000 |
| * | K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathSummary page 6…Name: Amplatz Type Renal Sheaths Device Classification Name: Catheter, Nephrostomy Regulation Description: None 510(k) Number: K172929 Regulation Number: None Device Class Unclassified Product Code: LJE In complia… | 2018 |
| * | — | LithAssist Suction Control for Laser Lithotripsy Named without a submission number | |
| † | K193534 | Monarch Platform | 2020 |
| † | K172048 | FluidSmart | 2017 |
| † | K141250 | Flexible Video-Uretero-Renoscope System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2024 | Class II | Z-0052-2025 | Device Design | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion… |
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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
- 6 other devices also cite its predicate K153049.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213334: Monarch Platform, Urology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213334
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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