510(k) · Cleared
ClearedOlympus Xcyf-TP3 Cystofiberscope/Nephrofiberscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · FCL Forceps, Biopsy, Non-Electric
Cleared on Jul 16, 2003 as substantially equivalent to K993041 (The Olympus Optical Co., 2000) and 1 other predicate after a 9-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jul 16, 2003
- Review
- 9 days
- Class
- Class I
- Product code
- FCL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931154 (1993). 12 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 2 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 1 generation backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- This deviceK032092 Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −2 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −1 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| 0 (this device) | K032092 | Olympus Xcyf-TP3 Cystofiberscope/Nephrofiberscope | Olympus Optical Co., Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 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 FCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K993041 | Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary EquipmentSummary page 5…s predicate devices in consideration of its characteristic and the following table shows regulatory history. Model 510(k)# ' Manufacturer Class | Product Code XCYF-1T3 #K993041 Olympus Optical Co., Ltd i 78FCL OES Cystrofiberscope/ 78FAJ Nephrofiberscope ‘ 78FGA Accessories and ancillary ' 78KOG equipment… | 2000 |
| * | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentSummary page 5…1T3 #K993041 Olympus Optical Co., Ltd i 78FCL OES Cystrofiberscope/ 78FAJ Nephrofiberscope ‘ 78FGA Accessories and ancillary ' 78KOG equipment 78FD{ 78KGE 78KNS XENF-DP #K011869 Olympus Optical Co., Ltd il EOB Laryngofiberscope, its Accessories and ancillary Equipment D. DEVICE DESCRIPTION 1. Summary The… | 2001 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K993041.
How does its category compare?
All FCL devicesFCL Forceps, Biopsy, Non-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCL
FDA has decided no FCL device since 2007.
Median 510(k) review, days · FCL
Too few FCL 510(k)s in any year since 2007 to give a median.
Recalls per year · FCL
3in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCL
55in 2025
MAUDE reports naming product code FCL, 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 | 58 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 0 | — | 0 | 410 |
| 2010 | 0 | — | 3 | 495 |
| 2011 | 0 | — | 0 | 377 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 0 | — | 0 | 86 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 64 |
| 2017 | 0 | — | 0 | 275 |
| 2018 | 0 | — | 0 | 69 |
| 2019 | 0 | — | 0 | 69 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 68 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus Light Source,
documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and
other ancillary equipment for endoscopic diagnosis and treatment within the bladder,
urethra and kidney.
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/K032092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032092: Olympus Xcyf-TP3 Cystofiberscope/Nephrofiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032092
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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