510(k) · Cleared
ClearedABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insung Medical Co., Ltd. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Dec 28, 2020 as substantially equivalent to K180253 (Teleflex Medical, 2018) after a 262-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Dec 28, 2020
- Review
- 262 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K771219 (1977). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK771219 Broncho-CathMallinckrodt Critical Care · 1977
- 4 generations backK051522 Silbroncho Double Lumen TubeFuji Systems Corp. · 2005
- 3 generations backK092886 Well Lead Endobronchial TubesWell Lead Instruments · 2010 · Recalled
- 2 generations backK141888 Rusch Endobronchial TubesTeleflexmedical, Inc. · 2015
- 1 generation backK180253 Sheridan Endobronchial TubesTeleflex Medical · 2018
- This deviceK200968 ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771219 | Broncho-Cath | Mallinckrodt Critical Care | 1977 | — |
| −4 | K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | 2005 | — |
| −3 | K092886 | Well Lead Endobronchial Tubes | Well Lead Instruments | 2010 | 1 |
| −2 | K141888 | Rusch Endobronchial Tubes | Teleflexmedical, Inc. | 2015 | — |
| −1 | K180253 | Sheridan Endobronchial Tubes | Teleflex Medical | 2018 | — |
| 0 (this device) | K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Insung Medical Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K180253 | Sheridan Endobronchial TubesSummary page 5…Predicate Device Manufacturer Teleflex Medical Device Name (Trade Name) Sheridan Endobronchial Tubes 510(k) Number K180253 4. SUBJECT DEVICE DESCRIPTION ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bron… | 2018 |
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 43 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2020, 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?
This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation.
The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200968: ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200968
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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