Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KTI — Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
266 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for | Cook Ireland, Ltd. | 2026-07-24 | 98 | 0 |
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | 2026-04-16 | 338 | 0 |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | 2026-03-12 | 86 | 0 |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 2025-12-19 | 227 | 0 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | 2025-10-08 | 28 | 0 |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Asp | Olympus Medical Systems Corporation | 2025-07-29 | 60 | 0 |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | 2025-03-31 | 61 | 0 |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-03-04 | 266 | 0 |
| K231818 | METIC™- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. | 2023-11-15 | 147 | 0 |
| K230778 | EndoCore | Praxis Medical, LLC | 2023-09-25 | 188 | 0 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | 2023-05-11 | 99 | 0 |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-01 | 222 | 0 |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | 2022-08-25 | 121 | 0 |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentT | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-20 | 301 | 0 |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | 2022-03-08 | 137 | 0 |
| K211894 | Trachealator | Disa Medinotec | 2021-11-24 | 156 | 0 |
| K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020-03-18 | 90 | 1 |
| K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | 2019-12-10 | 307 | 0 |
| K181193 | PeriView FLEX | Olympus Surgical Technologies America | 2018-07-03 | 60 | 0 |
| K171232 | PeriView FLEX | Olympus Surgical Technologies America | 2017-09-21 | 147 | 0 |
| K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017-06-23 | 102 | 0 |
| K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2017-04-06 | 115 | 0 |
| K161392 | Elation Pulmonary Balloon Dilation | Merit Medical Systems, Inc. | 2016-09-01 | 105 | 0 |
| K153484 | Dillard Airway Dilatation System | Intuit Medical Products, LLC | 2016-07-27 | 237 | 0 |
| K152922 | ViziShot FLEX | Spiration, Inc. | 2016-02-19 | 140 | 0 |
| K151522 | DEFENDO Bronchoscopy Suction Valve | Medivators, Inc. | 2015-09-17 | 104 | 0 |
| K150951 | aeris Balloon Dialation Catheter | Bryan Medical, Inc. | 2015-06-25 | 77 | 1 |
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | Acclarent, Inc. | 2011-03-31 | 65 | 9 |
| K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | Acclarent, Inc. | 2009-06-12 | 92 | 7 |
| K082174 | Y-ADAPTER | Asthmatx, Inc. | 2008-10-20 | 80 | 0 |
| K023337 | CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, | Boston Scientific Corp | 2002-11-18 | 42 | 0 |
| K020765 | MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M005132 | Boston Scientific Corp | 2002-04-05 | 28 | 0 |
| K833491 | ENDO BITE BLOCK | American Endoscopy, Inc. | 1984-04-25 | 201 | 0 |
| K781365 | SPARTA BRONCHIAL BRUSH | Sparta Instrument Corp. | 1978-08-14 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda