510(k) Report

510(k) · Cleared

Cleared

Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

K251950510(k) TraditionalCleared Mar 20, 2026268-day reviewClass II21 CFR 868.5740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hangzhou Tappa Medical Technology Co., Ltd. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Cleared on Mar 20, 2026 as substantially equivalent to K160542 (Cook Incorporated, 2016) and 2 other predicates after a 268-day review. Its family tree reaches back 4 generations to 1997.

Decided
Mar 20, 2026
Review
268 days
Class
Class II
Product code
CBI
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K962167 (1997). 8 ancestors in all, the oldest K894337 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1989: 1 other ancestorK962167 · Bronchial Blocker · Cook, Inc. · 1997K013865 · Tip Deflrcting Endobronchial Blocker · Cook, Inc. · 2002K071694 · Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX · Daiken Medical Co, Ltd. · 2008K093888 · Coopdech Endobronchial Blocker Tube · Daiken Medical Co, Ltd. · 20101990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K093888 · Coopdech Endobronchial Blocker Tube · Daiken Medical Co, Ltd. · 2010K071694 · Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX · Daiken Medical Co, Ltd. · 2008K013865 · Tip Deflrcting Endobronchial Blocker · Cook, Inc. · 2002K962167 · Bronchial Blocker · Cook, Inc. · 19970
  1. Root · 4 generations backK962167 Bronchial BlockerCook, Inc. · 1997
  2. 3 generations backK013865 Tip Deflrcting Endobronchial BlockerCook, Inc. · 2002
  3. 2 generations backK071694 Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008
  4. 1 generation backK093888 Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010
  5. This deviceK251950 Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube…Hangzhou Tappa Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962167Bronchial BlockerCook, Inc.1997—
−3K013865Tip Deflrcting Endobronchial BlockerCook, Inc.2002—
−2K071694Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd.2008—
−1K093888Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd.2010—
0 (this device)K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…Hangzhou Tappa Medical Technology Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
200010
200210
201610
FIG. 1 — Lineage of K251950, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253096 Chartis Precision Catheterscore 12.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K1605425.0 Fr Arndt Endobronchial Blocker Set
Summary page 5
…lation (W/Wo Connector) Classification Name: Regulation Number: 21 CFR 868.5740 Product Code: CBI Device Class: Class II Predicate device: K160542 & K021920 - Arndt Endobronchial Blocker Set K093888 - COOPDECH ENDOBRONCHIAL BLOCKER TUBE 3. Indications…
Cook Incorporated2016—
*K0219207.0 FR. Endobronchial Blocker
Summary page 5
…Wo Connector) Classification Name: Regulation Number: 21 CFR 868.5740 Product Code: CBI Device Class: Class II Predicate device: K160542 & K021920 - Arndt Endobronchial Blocker Set K093888 - COOPDECH ENDOBRONCHIAL BLOCKER TUBE 3. Indications for use…
Cook, Inc.2002—
*K093888Coopdech Endobronchial Blocker Tube
Summary page 5
…868.5740 Product Code: CBI Device Class: Class II Predicate device: K160542 & K021920 - Arndt Endobronchial Blocker Set K093888 - COOPDECH ENDOBRONCHIAL BLOCKER TUBE 3. Indications for use The Endobronchial Blocker Tube is intended to differentially intub…
Daiken Medical Co, Ltd.2010—

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 29 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
  • None of the 8 ancestors has a recall.

How does its category compare?

All CBI devices

CBI 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

2008: 12009: 12010: 22011: 12012: 32013: 12015: 12016: 22018: 22020: 12021: 22022: 12023: 12024: 12026 (partial year): 2
2007high 3 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBI

134in 2012

2012: 134 days median
2007high 134 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CBI

1in 2024

2019: 12024: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CBI

83in 2025

2007: 112008: 162009: 262010: 252011: 202012: 232013: 262014: 182015: 82016: 292017: 612018: 662019: 942020: 872021: 1592022: 1272023: 952024: 752025: 83
2007high 159 (2021) · low 8 (2015)2025

MAUDE reports naming product code CBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—011
20081—016
20091—026
20102—025
20111—020
20123134023
20131—026
20140—018
20151—08
20162—029
20170—061
20182—066
20190—194
20201—087
20212—0159
20221—0127
20231—095
20241—175
20250—083
20262—0—

What is it indicated for?

The Endobronchial Blocker Tube 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 5Fr Endobronchial Blocker Tube is indicated for pediatric populations, in children with minimum 10 Kg of weight. All other sizes are for adult use only.

Indications for use as stated in the FDA summary.

More from Hangzhou Tappa Medical Technology Co.…

3 FDA decisions under this applicant name. See the company

  • K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026
  • K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026

Recent decisions in CBI

The CBI category page

  • K253096Chartis Precision CatheterPulmonx Corporation · 2026
  • K232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd. · 2024
  • K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd. · 2023
  • K222340Chartis Precision CatheterPulmonx Corporation · 2022
  • K201026sOLVe TubeHytek Medical, Inc. · 2021

https://510kreport.com/device/K251950 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251950: Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251950

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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