KTI
- Product code
- KTI
- Device name
- Bronchoscope Accessory
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
FDA classification 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).
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261274 | 2026-07-24 | Cook Ireland, Ltd. | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Ne… | |
| K251478 | 2026-04-16 | Finemedix Co., Ltd. | ClearTip TBNA Type | |
| K254040 | 2026-03-12 | Free Flow Medical, Inc. | LungFlow Basket Catheter | |
| K251402 | 2025-12-19 | Leadoptik, Inc. | LIA-1 Catheter (542-1) | |
| K252874 | 2025-10-08 | Serpex Medical, Inc. | Compass Steerable Needle with Adapters SRA-1-01 and … | FDA |
| K251664 | 2025-07-29 | Olympus Medical Systems Corporation | Single Use Aspiration Needle (NA-201SX-4021); Singl… | |
| K250263 | 2025-03-31 | Olympus Medical Systems Corp. | Disposable Grasping Forceps FG-52D/FG-54D | |
| K241679 | 2025-03-04 | Alton (Shanghai) Medical Instruments C… | Disposable Cytology Brush (AF series) | |
| K231818 | 2023-11-15 | M/S Meril Life Sciences Pvt. , Ltd. | METIC- Airway Balloon Catheter | |
| K230778 | 2023-09-25 | Praxis Medical, LLC | EndoCore |
Official FDA classification page: KTI
Classification and pathway per current FDA publications. Data from openFDA (CC0).