510(k) · Cleared
ClearedGyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · FGA Kit, Nephroscope
Cleared on Dec 13, 2007 as substantially equivalent to K060269 (Acmi Corporation, 2006) and 2 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1993. 1 of the 49 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Dec 13, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- FGA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931154 (1993). 25 ancestors in all, the oldest K791182 (1979). 23 later devices descend from it, 1 citing it directly. 1 of the 49 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 3 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 2 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 1 generation backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- This deviceK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- Descendant · cites it directly · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- Descendant · 2 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- Descendant · 3 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- Descendant · 3 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK202445 Hystero-V HysteroscopeHysterovue, Inc. · 2021
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope5 generations back · 1991
Most influential descendants
Showing 5 of 23 · See all- K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · cites it directly22descendants
- K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 2 generations on20descendants
- K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 3 generations on19descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 3 generations on5descendants
- K202445Hystero-V HysteroscopeHysterovue, Inc. · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −3 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −1 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| 0 (this device) | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
| +1 | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| +2 | K123151 | Endosee Model 8000 U-Scope | Endosee Corp | 2013 | — |
| +3 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| +3 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +4 | K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemSummary page 1…® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System Generic/Common Name: Endoscope, Video Camera and accessories Predicate Devices ACMI® DUR-Digital Ureteroscope K060269 and Choledochoscope System ACMI® MRO™ .20 K791182 Rigid Percutaneous Nephroscopes ACMI® MR-6A/MR-6LA K052044 Autoclavable Ureter… | 2006 |
| * | K791182 | Acmi Rigi-Flex NephorscopeSummary page 1…pe System Generic/Common Name: Endoscope, Video Camera and accessories Predicate Devices ACMI® DUR-Digital Ureteroscope K060269 and Choledochoscope System ACMI® MRO™ .20 K791182 Rigid Percutaneous Nephroscopes ACMI® MR-6A/MR-6LA K052044 Autoclavable Ureteroscopes Intended Uses The Gyrus ACMI® IPN-2505,… | 1979 |
| * | K052044 | Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALSummary page 1…accessories Predicate Devices ACMI® DUR-Digital Ureteroscope K060269 and Choledochoscope System ACMI® MRO™ .20 K791182 Rigid Percutaneous Nephroscopes ACMI® MR-6A/MR-6LA K052044 Autoclavable Ureteroscopes Intended Uses The Gyrus ACMI® IPN-2505, Invisio® Smith™ Percutaneous Nephroscope System (which incl… | 2005 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | 2009 | 22 |
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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K092278 (Gyrus Acmi, Inc., 2009) has gone furthest, with 22 descendants of its own.
- 6 other devices also cite its predicate K060269.
How does its category compare?
All FGA devicesFGA Kit, Nephroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Gyrus ACMI® IPN-2505, Invisio® SmithTM Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® SmithTM Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic 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/K072594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072594: Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072594
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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