510(k) · Cleared
ClearedChartis Precision Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmonx Corporation · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Feb 13, 2026 as substantially equivalent to K222340 (Pulmonx Corporation, 2022) after a 143-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Feb 13, 2026
- Review
- 143 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894337 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK894337 Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MMVitaid, Ltd. · 1989
- 4 generations backK021920 7.0 FR. Endobronchial BlockerCook, Inc. · 2002
- 3 generations backK083883 Chartis CatheterPulmonx, Inc. · 2009
- 2 generations backK111522 Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc. · 2011
- 1 generation backK222340 Chartis Precision CatheterPulmonx Corporation · 2022
- This deviceK253096 Chartis Precision CatheterPulmonx Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894337 | Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | Vitaid, Ltd. | 1989 | — |
| −4 | K021920 | 7.0 FR. Endobronchial Blocker | Cook, Inc. | 2002 | — |
| −3 | K083883 | Chartis Catheter | Pulmonx, Inc. | 2009 | — |
| −2 | K111522 | Chartis Catheter Model CHR-CA-12.0 | Pulmonx, Inc. | 2011 | — |
| −1 | K222340 | Chartis Precision Catheter | Pulmonx Corporation | 2022 | — |
| 0 (this device) | K253096 | Chartis Precision Catheter | Pulmonx Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBI device
- #1 K251950 Endobronchial Blocker Tube (EBT0109)…score 11.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222340 | Chartis Precision CatheterSummary page 5…Predicate Devices The subject Chartis Precision Catheter is substantially equivalent to the predicate device Pulmonx Chartis Precision Catheter cleared in K222340. D. Device Description The Chartis Precision Catheter is a single-use, sterile balloon catheter designed for use… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All CBI devicesCBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · CBI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBI
134in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBI
83in 2025
MAUDE reports naming product code CBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 1 | — | 0 | 26 |
| 2010 | 2 | — | 0 | 25 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 3 | 134 | 0 | 23 |
| 2013 | 1 | — | 0 | 26 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 2 | — | 0 | 66 |
| 2019 | 0 | — | 1 | 94 |
| 2020 | 1 | — | 0 | 87 |
| 2021 | 2 | — | 0 | 159 |
| 2022 | 1 | — | 0 | 127 |
| 2023 | 1 | — | 0 | 95 |
| 2024 | 1 | — | 1 | 75 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is capital equipment that is reusable and displays the patient information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253096: Chartis Precision Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253096
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026