510(k) · Cleared
ClearedDEFENDO Bronchoscopy Suction Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivators, Inc. · KTI Bronchoscope Accessory
Cleared on Sep 17, 2015 as substantially equivalent to K920025 (Olympus Corp., 1992) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Sep 17, 2015
- Review
- 104 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001241 (2000). 3 ancestors in all, the oldest K920025 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK001241 Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co. · 2000 · Recalled
- 1 generation backK102581 Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc. · 2010
- This deviceK151522 DEFENDO Bronchoscopy Suction ValveMedivators, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I | The Olympus Optical Co. | 2000 | 1 |
| −1 | K102581 | Defendo Disposable Suction Valve Model 100305 | Byrne Medical, Inc. | 2010 | — |
| 0 (this device) | K151522 | DEFENDO Bronchoscopy Suction Valve | Medivators, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 KTI? 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? (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 |
|---|---|---|---|
| * | K920025 | Olympus Disposable Suction ValveSummary page 5…Suction Valve is equivalent in function, intended use and scientific technology to its predicate devices - Olympus Disposable Suction Valve cleared under 510(k) – K920025 and Defendo Disposable Suction Valve cleared under 510(k) – K102581. Similarities between Subject and Predicate Devices - Sub… | 1992 |
| * | K102581 | Defendo Disposable Suction Valve Model 100305Summary page 5…c technology to its predicate devices - Olympus Disposable Suction Valve cleared under 510(k) – K920025 and Defendo Disposable Suction Valve cleared under 510(k) – K102581. Similarities between Subject and Predicate Devices - Subject and predicate devices have similar intended use, principle o… | 2010 |
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 15 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K920025.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151522: DEFENDO Bronchoscopy Suction Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151522
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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