510(k) · Cleared
ClearedMicrovasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KTI Bronchoscope Accessory
Cleared on Apr 5, 2002 as substantially equivalent to K962367 (Olympus America, Inc., 1996) after a 28-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Apr 5, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962367 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK962367 Olympus Basket GraspersOlympus America, Inc. · 1996
- This deviceK020765 Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and…Boston Scientific Corp · 2002
- Descendant · cites it directly · 0 of its ownK254040 LungFlow Basket CatheterFree Flow Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250263 Disposable Grasping Forceps FG-52D/FG-54DOlympus Medical Systems Corp. · 2025
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 |
|---|---|---|---|---|---|
| −1 | K962367 | Olympus Basket Graspers | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K020765 | Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210 | Boston Scientific Corp | 2002 | — |
| +1 | K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | 2026 | — |
| +1 | K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | 2025 | — |
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.
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 |
|---|---|---|---|
| * | K962367 | Olympus Basket GraspersSummary page 3…way Retricval Basket Proposcd Microvasive” Zelo | Microvasive” Zero Tip | Olympus® Baskct Tip™ Airway Retricval Stone Retrieval Basket Grasping Forceps Basket {Exempt) (K962367) (This 510(k)) USE Indication Intended to be used to Intended to be used Intended 1o retrieve endoscopically remove during urolog… | 1996 |
| * | — | Microvasive® Zero Tip Stone Retrieval Basket Named without a submission number |
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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K254040 (Free Flow Medical, Inc., 2026) has gone furthest, with 0 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.
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 Microvasive® Zero Tip™ Airway Retrieval Basket is indicated to be used to endoscopically remove foreign bodies from the airway.
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/K020765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020765: Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020765
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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