Chartis Precision Catheter
FDA 510(k) K253096 · Pulmonx Corporation
510(k) numberK253096
Submission
- Device name
- Chartis Precision Catheter
- Applicant
- Pulmonx Corporation
Redwood City, CA, US - Received
- September 23, 2025
- Decision date
- February 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5740
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…CBI · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 03/20/2026SE |
| K232529 | Disposable Double Lumen Endobronchial TubeCBI · Traditional | Shenzhen Insighters Medical Technology Co., Ltd. | 05/13/2024SE |
| K232580 | Disposable Endobronchial Blocker TubeCBI · Traditional | Shenzhen Insighters Medical Technology Co., Ltd. | 12/14/2023SE |
| K222340 | Chartis Precision CatheterCBI · Traditional | Pulmonx Corporation | 12/01/2022SE |
| K201026 | sOLVe TubeCBI · Traditional | Hytek Medical, Inc. | 08/10/2021SE |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableCBI · Traditional | Ambu A/S | 05/03/2021SE |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RCBI · Traditional | Insung Medical Co., Ltd. | 12/28/2020SE |
| K181886 | VivaSight-DL SystemCBI · Special | Etview , Ltd. | 11/14/2018SE |
| K180253 | Sheridan Endobronchial TubesCBI · Traditional | Teleflex Medical | 11/02/2018SE |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker SetCBI · Special | Cook Incorporated | 08/02/2016SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K222340 | Chartis Precision CatheterCBI · Traditional | 12/01/2022SE |
| K212494 | Lung Image AnalysisJAK · Traditional | 09/02/2021SE |
| K180011 | Pulmonx Chartis Tablet ConsoleBZG · Traditional | 07/13/2018SE |
| K111764 | Chartis ConsoleBZG · Special | 11/10/2011SE |
| K111522 | Chartis Catheter Model CHR-CA-12.0CBI · Special | 09/29/2011SE |
| K083883 | Chartis CatheterCBI · Traditional | 06/25/2009SE |
| K083199 | Chartis ConsoleBZG · Traditional | 06/25/2009SE |
| K973191 | The Visualized Endotracheal Tube System or Vett SystemBTR · Traditional | 02/13/1998SE |
Questions and answers
When was Chartis Precision Catheter cleared by the FDA?
Chartis Precision Catheter (K253096) received a 510(k) decision of Substantially Equivalent on February 13, 2026, 143 days after the submission was received.
What is the product code of K253096?
The FDA product code is CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5740.