510(k) · Cleared
ClearedViziShot 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 Apr 6, 2017 as substantially equivalent to K152922 (Spiration, Inc., 2016) after a 115-day review. Its family tree reaches back 11 generations to 1989. 1 of the 63 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Apr 6, 2017
- Review
- 115 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894632 (1989). 57 ancestors in all, the oldest K812810 (1981). 5 later devices descend from it, 2 citing it directly. 1 of the 63 devices in this family, counting this one, has 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 backK142909 Flexible 19G EBUS NeedleSpiration, Inc. · 2015
- 1 generation backK152922 ViziShot FLEXSpiration, Inc. · 2016
- This deviceK163469 ViziShot 2 FLEXOlympus Surgical Technologies America · 2017
- Descendant · cites it directly · 2 of its ownK190239 Single Use Aspiration NeedleOlympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 1 of its ownK213060 AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM…Micro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251478 ClearTip TBNA TypeFinemedix Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251664 Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration…Olympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK230778 EndoCorePraxis Medical, LLC · 2023
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 backK142909 Flexible 19G EBUS NeedleSpiration, Inc. · 2015
- 1 generation backK152922 ViziShot FLEXSpiration, Inc. · 2016
- This deviceK163469 ViziShot 2 FLEXOlympus Surgical Technologies America · 2017
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…6 generations back · 2003
Most influential descendants
Showing 5 of 5 · See all- K190239Single Use Aspiration NeedleOlympus Medical Systems Corp. · 2019 · cites it directly2descendants
- K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd. · 2022 · cites it directly1descendant
- K251478ClearTip TBNA TypeFinemedix Co., Ltd. · 2026 · 2 generations on0descendants
- K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K230778EndoCorePraxis Medical, LLC · 2023 · 2 generations on0descendants
View 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 | K142909 | Flexible 19G EBUS Needle | Spiration, Inc. | 2015 | — |
| −1 | K152922 | ViziShot FLEX | Spiration, Inc. | 2016 | — |
| 0 (this device) | K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2017 | — |
| +1 | K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial… | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +2 | K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | 2026 | — |
| +2 | K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle… | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K230778 | EndoCore | Praxis Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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.
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 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 |
|---|---|---|---|
| * | K152922 | ViziShot FLEXSummary page 4…ViziShot 2 FLEX Generic/Common Name: Aspiration Needle Predicate Devices Spiration, Inc. ViziShot FLEX K152922 6 Gyrus ACMI Vizi… | 2016 |
What descends from it? (5)
2 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.
- 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 28 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 57 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190239 (Olympus Medical Systems Corp., 2019) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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) 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/K163469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163469: ViziShot 2 FLEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163469
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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