510(k) · Cleared
ClearedChartis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmonx, Inc. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Jun 25, 2009 as substantially equivalent to K021920 (Cook, Inc., 2002) after a 178-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.
- Decided
- Jun 25, 2009
- Review
- 178 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894337 (1989). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK894337 Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MMVitaid, Ltd. · 1989
- 1 generation backK021920 7.0 FR. Endobronchial BlockerCook, Inc. · 2002
- This deviceK083883 Chartis CatheterPulmonx, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK111522 Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK222340 Chartis Precision CatheterPulmonx Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK253096 Chartis Precision CatheterPulmonx Corporation · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894337 | Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | Vitaid, Ltd. | 1989 | — |
| −1 | K021920 | 7.0 FR. Endobronchial Blocker | Cook, Inc. | 2002 | — |
| 0 (this device) | K083883 | Chartis Catheter | Pulmonx, Inc. | 2009 | — |
| +1 | K111522 | Chartis Catheter Model CHR-CA-12.0 | Pulmonx, Inc. | 2011 | — |
| +2 | K222340 | Chartis Precision Catheter | Pulmonx Corporation | 2022 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 K253096 Chartis Precision Catheterscore 12.1 · 5 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 |
|---|---|---|---|
| * | K021920 | 7.0 FR. Endobronchial BlockerSummary page 1…ces: The Chartis Catheter is substantially equivalent to the following currently marketed predicate device: (1) Endobronchial Blocker marketed by Cook. (K021920, cleared August 14, 2002, product code CBI, regulation number 868.5740) Device Description: The Chartis Cathete… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111522 | Chartis Catheter Model CHR-CA-12.0 | 2011 | 2 |
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 20 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111522 (Pulmonx, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K021920.
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. 2009, 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 diagnostic bronchoscopy in adult patients 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 a re-useable piece of capital equipment that displays the patient information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083883: Chartis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083883
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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