Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CBI — Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
276 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 | 268 | 0 |
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | 2026-02-13 | 143 | 0 |
| K232529 | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2024-05-13 | 266 | 0 |
| K232580 | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2023-12-14 | 111 | 0 |
| K222340 | Chartis Precision Catheter | Pulmonx Corporation | 2022-12-01 | 120 | 0 |
| K201026 | sOLVe Tube | Hytek Medical, Inc. | 2021-08-10 | 477 | 0 |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | 2021-05-03 | 131 | 1 |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC3 | Insung Medical Co., Ltd. | 2020-12-28 | 262 | 0 |
| K181886 | VivaSight-DL System | Etview , Ltd. | 2018-11-14 | 124 | 0 |
| K180253 | Sheridan Endobronchial Tubes | Teleflex Medical | 2018-11-02 | 276 | 0 |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker Set | Cook Incorporated | 2016-08-02 | 158 | 0 |
| K152251 | Endobronchial Tube | Henan Tuoren Medical Device Co., Ltd. | 2016-06-10 | 305 | 0 |
| K141888 | RUSCH ENDOBRONCHIAL TUBES | Teleflexmedical, Inc. | 2015-04-15 | 275 | 0 |
| K123853 | VIVASIGHT-DL SYSTEM | Etview , Ltd. | 2013-04-15 | 122 | 0 |
| K121462 | EZ-BLOCKER | Ez-Blocker B.V. | 2012-09-28 | 134 | 0 |
| K120334 | VIVA EB | Etview , Ltd. | 2012-06-08 | 126 | 0 |
| K113576 | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | Etview , Ltd. | 2012-05-18 | 165 | 0 |
| K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 | Pulmonx, Inc. | 2011-09-29 | 119 | 0 |
| K093888 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE | Daiken Medical Co, Ltd. | 2010-03-16 | 88 | 0 |
| K092886 | WELL LEAD ENDOBRONCHIAL TUBES | Well Lead Instruments | 2010-03-11 | 171 | 1 |
| K083883 | CHARTIS CATHETER | Pulmonx, Inc. | 2009-06-25 | 178 | 0 |
| K071694 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT- | Daiken Medical Co, Ltd. | 2008-03-20 | 274 | 0 |
| K051522 | SILBRONCHO DOUBLE LUMEN TUBE | Fuji Systems Corp. | 2005-08-17 | 70 | 0 |
| K021920 | 7.0 FR. ENDOBRONCHIAL BLOCKER | Cook, Inc. | 2002-08-14 | 64 | 0 |
| K013865 | TIP DEFLRCTING ENDOBRONCHIAL BLOCKER | Cook, Inc. | 2002-04-22 | 152 | 0 |
| K010596 | RUSCH BRONCHUS BLOCKER KIT | Rusch Intl. | 2001-11-21 | 266 | 0 |
| K002288 | ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER | Cook, Inc. | 2000-11-28 | 124 | 0 |
| K962167 | BRONCHIAL BLOCKER | Cook, Inc. | 1997-08-29 | 450 | 0 |
| K961977 | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-07-31 | 72 | 2 |
| K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | Smiths Industries Medical Systems, Inc. | 1995-10-24 | 91 | 0 |
| K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE | Sorin Biomedica, Fiat, USA, Inc. | 1993-03-26 | 140 | 5 |
| K897046 | LASER RESISTANT TRACHEAL TUBE | Sheridan Catheter Corp. | 1990-03-23 | 95 | 0 |
| K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | Vitaid, Ltd. | 1989-09-29 | 77 | 0 |
| K851856 | TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE | Sheridan Catheter Corp. | 1985-05-23 | 27 | 3 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda