510(k) · Cleared
Cleared5.0 Fr Arndt Endobronchial Blocker Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Aug 2, 2016 as substantially equivalent to K962167 (Cook, Inc., 1997) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Aug 2, 2016
- Review
- 158 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962167 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK962167 Bronchial BlockerCook, Inc. · 1997
- This deviceK160542 5.0 Fr Arndt Endobronchial Blocker SetCook Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK251950 Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube…Hangzhou Tappa Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…Hangzhou Tappa Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962167 | Bronchial Blocker | Cook, Inc. | 1997 | — |
| 0 (this device) | K160542 | 5.0 Fr Arndt Endobronchial Blocker Set | Cook Incorporated | 2016 | — |
| +1 | K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)… | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 12.0 · 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? (2)
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 |
|---|---|---|---|
| * | K962167 | Bronchial BlockerSummary page 4…e: Tracheal/bronchial differential ventilation tube Regulation 21 CFR §868.5740 Product Code CBI Predicate Devices: K962167, Bronchial Blocker K002288, Arndt Pediatric Endobronchial Blocker Device Description: The 5.0 Fr Arndt Endobronchial Blo… | 1997 |
| * | K002288 | Arndt Pediatric Endobronchial BlockerSummary page 4…ferential ventilation tube Regulation 21 CFR §868.5740 Product Code CBI Predicate Devices: K962167, Bronchial Blocker K002288, Arndt Pediatric Endobronchial Blocker Device Description: The 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endo… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)… | 2026 | 0 |
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?
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. 2016, 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 5.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient’s bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older.
The 9.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient’s bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160542: 5.0 Fr Arndt Endobronchial Blocker Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160542
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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