510(k) · Cleared
Recalled · Class I · 2025ViziShot 2 FLEX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Surgical Technologies America · KTI Bronchoscope Accessory
Cleared on Mar 18, 2020 as substantially equivalent to K160229 (Cook Ireland, Ltd., 2016) after a 90-day review. Its family tree reaches back 11 generations to 1989. 2 of the 71 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 18, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- KTI
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894632 (1989). 68 ancestors in all, the oldest K812810 (1981). 2 later devices descend from it, 2 citing it directly. 2 of the 71 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations between
- 3 generations backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- 2 generations backK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- 1 generation backK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- This deviceK193517 ViziShot 2 FLEXOlympus Surgical Technologies America · 2020
- Descendant · cites it directly · 0 of its ownK261274 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for…Cook Ireland, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251402 LIA-1 Catheter (542-1)Leadoptik, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 10 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 9 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 8 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 7 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 6 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 5 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 4 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 3 generations backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- 2 generations backK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- 1 generation backK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- This deviceK193517 ViziShot 2 FLEXOlympus Surgical Technologies America · 2020
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…6 generations back · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −10 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −9 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −8 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −7 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −6 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −5 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −3 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| −2 | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model… | Cook Ireland, Ltd. | 2010 | — |
| −1 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
| 0 (this device) | K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020 | — |
| +1 | K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes… | Cook Ireland, Ltd. | 2026 | — |
| +1 | K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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.
2 devices in this family have 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 KTI device
- #1 K261274 EchoTip Ultra® Endobronchial HD Ultrasound…score 15.0 · 12 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 |
|---|---|---|---|
| * | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Summary page 4…me: Aspiration Needle Predicate Device Cook Ireland, Ltd Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle K160229 Reference Device Gyrus ACMI ViziShot 2 FLEX K163469… | 2016 |
| † | K163469 | ViziShot 2 FLEX | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2025 | Class I | Z-2484-2025 | Process design | Potential for undetected, deformed a-traumatic tips. |
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 17 of the 68 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K261274 (Cook Ireland, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160229.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KTI
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTI
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTI
198in 2025
MAUDE reports naming product code KTI, 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 | 3 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 12 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 140 | 0 | 7 |
| 2017 | 3 | 115 | 0 | 9 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 27 |
| 2020 | 1 | — | 0 | 37 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 3 | 137 | 0 | 131 |
| 2023 | 4 | 168 | 0 | 130 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 5 | 61 | 0 | 198 |
| 2026 | 3 | 98 | 0 | — |
What is it indicated for?
The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
Do not use this device for any purpose other than its intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193517: ViziShot 2 FLEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193517
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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