Trachealator
FDA 510(k) K211894 · Disa Medinotec
510(k) numberK211894
Submission
- Device name
- Trachealator
- Applicant
- Disa Medinotec
Johannesburg, ZA - Received
- June 21, 2021
- Decision date
- November 24, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTI – Bronchoscope Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
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).
Other 510(k)s with product code KTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…KTI · Traditional | Cook Ireland, Ltd. | 07/24/2026SE |
| K251478 | ClearTip TBNA TypeKTI · Traditional | Finemedix Co., Ltd. | 04/16/2026SE |
| K254040 | LungFlow Basket CatheterKTI · Traditional | Free Flow Medical, Inc. | 03/12/2026SE |
| K251402 | LIA-1 Catheter (542-1)KTI · Traditional | Leadoptik, Inc. | 12/19/2025SE |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01KTI · Special | Serpex Medical, Inc. | 10/08/2025SE |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)KTI · Traditional | Olympus Medical Systems Corporation | 07/29/2025SE |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54DKTI · Traditional | Olympus Medical Systems Corp. | 03/31/2025SE |
| K241679 | Disposable Cytology Brush (AF series)KTI · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 03/04/2025SE |
| K231818 | METIC- Airway Balloon CatheterKTI · Traditional | M/S Meril Life Sciences Pvt. , Ltd. | 11/15/2023SE |
| K230778 | EndoCoreKTI · Traditional | Praxis Medical, LLC | 09/25/2023SE |
More from Praxis Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K241562 | OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional | 03/11/2025SE |
Questions and answers
When was Trachealator cleared by the FDA?
Trachealator (K211894) received a 510(k) decision of Substantially Equivalent on November 24, 2021, 156 days after the submission was received.
What is the product code of K211894?
The FDA product code is KTI – Bronchoscope Accessory, a Class II (moderate risk) device regulated under 21 CFR 874.4680.