Atlas FDA

KTI

34 FDA 510(k) clearances · Product code

105 daysmedian time to decision
266 days90th percentile
34clearances measured

FDA profile

Official device name
Bronchoscope Accessory
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4680
Medical specialty
Ear, Nose, Throat
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 47 · 2022: 131 · 2023: 130 · 2024: 149 · 2025: 199 · 2026: 130
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (K261274)Cook Ireland, Ltd.2026-07-24
ClearTip TBNA Type (K251478)Finemedix Co., Ltd.2026-04-16
LungFlow Basket Catheter (K254040)Free Flow Medical, Inc.2026-03-12
LIA-1 Catheter (542-1) (K251402)Leadoptik, Inc.2025-12-19
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (K252874)Serpex Medical, Inc.2025-10-08
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664)Olympus Medical Systems Corporation2025-07-29
Disposable Grasping Forceps FG-52D/FG-54D (K250263)Olympus Medical Systems Corp.2025-03-31
Disposable Cytology Brush (AF series) (K241679)Alton (Shanghai) Medical Instruments Co., Ltd.2025-03-04
METIC™- Airway Balloon Catheter (K231818)M/S Meril Life Sciences Pvt. , Ltd.2023-11-15
EndoCore (K230778)Praxis Medical, LLC2023-09-25
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280)Ga Health Company Limited2023-05-11
Multistage Balloon Dilatation Catheter (K222187)Dongguan TT Medical, Inc.2023-03-01
Compass Steerable Needle (K221206)Serpex Medical, Inc.2022-08-25
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle (K213060)Micro-Tech (Nanjing) Co., Ltd.2022-07-20
Elation Pulmonary Balloon Dilation Catheter (K213434)Merit Medical Systems, Inc.2022-03-08
Trachealator (K211894)Disa Medinotec2021-11-24
ViziShot 2 FLEX (K193517)Olympus Surgical Technologies America2020-03-18
Single Use Aspiration Needle (K190239)Olympus Medical Systems Corp.2019-12-10
PeriView FLEX (K181193)Olympus Surgical Technologies America2018-07-03
PeriView FLEX (K171232)Olympus Surgical Technologies America2017-09-21
CRE Pulmonary Balloon Dilatation Catheter (K170759)Boston Scientific Corporation2017-06-23
ViziShot 2 FLEX (K163469)Olympus Surgical Technologies America2017-04-06
Elation Pulmonary Balloon Dilation (K161392)Merit Medical Systems, Inc.2016-09-01
Dillard Airway Dilatation System (K153484)Intuit Medical Products, LLC2016-07-27
ViziShot FLEX (K152922)Spiration, Inc.2016-02-19
DEFENDO Bronchoscopy Suction Valve (K151522)Medivators, Inc.2015-09-17
aeris Balloon Dialation Catheter (K150951)Bryan Medical, Inc.2015-06-25
INSPIRA AIR BALLOON DILATION SYSTEM (K110218)Acclarent, Inc.2011-03-31
AIRWAY BALLOON CATHETER INFLATION DEVICE (K090660)Acclarent, Inc.2009-06-12
Y-ADAPTER (K082174)Asthmatx, Inc.2008-10-20
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 (K023337)Boston Scientific Corp2002-11-18
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 (K020765)Boston Scientific Corp2002-04-05
ENDO BITE BLOCK (K833491)American Endoscopy, Inc.1984-04-25
SPARTA BRONCHIAL BRUSH (K781365)Sparta Instrument Corp.1978-08-14

Track KTI automatically

Every clearance here is in the API, with alerts when new ones post.