510(k) · Cleared
ClearedEZ-Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ez-Blocker B.V. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Sep 28, 2012 as substantially equivalent to K021920 (Cook, Inc., 2002) after a 134-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Sep 28, 2012
- Review
- 134 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. No later device cites it as a predicate yet.
View 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) | K121462 | EZ-Blocker | Ez-Blocker B.V. | 2012 | — |
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 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? (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 2…Substantial Equivalence: Feature Cook Inc. Endobronchial EZ-Blocker® ______________ Blocker, K021920 This submission Indication for Use The 7.0 Fr. Endobronchial The EZ-Blocker is indicate… | 2002 |
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 23 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.
- 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. 2012, 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 EZ-Blocker is indicated for use to intubate the patient's bronchi in order to
differentialy isolate the left or right lung for procedures which require one-lung
ventilation, lung separation. Patient population: Patients requiring one lung isolation.
Environment of use: Hospitals - OR and ICU.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121462: EZ-Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121462
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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