Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BTR — Predicate Candidate Screening
241 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
294 days90th percentile
241clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253437 | Spiro-VISTA | Spiro Robotics | 2026-06-12 | 254 | 0 |
| K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) | Covidien, LLC | 2025-10-06 | 258 | 0 |
| K243785 | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinf | Covidien, LLC | 2025-09-25 | 290 | 0 |
| K243579 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | 2025-08-13 | 267 | 0 |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intub | William Cook Europe Aps | 2025-06-11 | 27 | 0 |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size | Flexicare Medical Limited. | 2025-05-20 | 113 | 0 |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | 2025-04-29 | 250 | 0 |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tu | Teleflex Incorporated | 2025-02-11 | 265 | 0 |
| K233341 | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non- | Covidien, LLC | 2024-05-20 | 234 | 0 |
| K223130 | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGua | Covidien | 2023-08-30 | 331 | 0 |
| K211543 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | 2022-07-21 | 428 | 0 |
| K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2021-10-21 | 30 | 0 |
| K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2020-11-25 | 246 | 0 |
| K192120 | Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ET | Venner Medical (Singapore) Pte, Ltd. | 2020-02-14 | 192 | 0 |
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tub | Salter Labs, Inc. | 2020-01-10 | 281 | 0 |
| K182739 | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | 2019-12-11 | 439 | 0 |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Teleflexmedical, Inc. | 2019-12-06 | 101 | 0 |
| K190630 | SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC | 2019-10-09 | 211 | 0 |
| K190213 | Yikang Endotracheal Tube | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2019-09-06 | 214 | 0 |
| K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019-07-30 | 172 | 0 |
| K181880 | VivaSight-SL (TVT) system | Etview , Ltd. | 2018-11-29 | 139 | 0 |
| K171917 | Frova Intubating Introducer | Cook Incorporated | 2018-04-23 | 300 | 0 |
| K172208 | NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) wi | Nevap, Inc. | 2018-02-16 | 207 | 0 |
| K170234 | Endotracheal tube; Reinforced Endotracheal tube | Zhanjiang Star Enterprise Co., Ltd. | 2018-01-17 | 357 | 0 |
| K171411 | IRRIS (Infra-Red-Red Intubation System) | A.R Guide IN Medical , Ltd. | 2018-01-12 | 242 | 0 |
| K161813 | Frova Intubating Introducer | William Cook Europe Aps | 2017-05-19 | 322 | 0 |
| K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017-04-07 | 389 | 0 |
| K152438 | ETView VivaSight-SL (TVT) system | Etview , Ltd. | 2016-02-25 | 182 | 0 |
| K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Mu | Covidien | 2015-12-11 | 203 | 0 |
| K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube | Teleflexmedical, Inc. | 2015-11-27 | 262 | 0 |
| K141747 | RHINOGUARD | Davis Medical | 2015-04-20 | 294 | 0 |
| K140228 | DISPOSABLE TRACHEAL TUBE | Suzhou Weikang Medical Apparatus Co., Ltd. | 2014-12-18 | 322 | 0 |
| K141939 | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECR | Teleflexmedical, Inc. | 2014-11-24 | 130 | 0 |
| K132415 | RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE | Teleflexmedical, Inc. | 2014-06-06 | 308 | 0 |
| K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | Kimberly-Clark Corp. | 2013-08-20 | 110 | 5 |
| K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | Kimberly-Clark Corp. | 2012-12-19 | 261 | 0 |
| K111401 | BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 | 427 | 0 |
| K111406 | BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), B | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 | 427 | 0 |
| K121028 | ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) | Etview , Ltd. | 2012-06-21 | 77 | 0 |
| K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADUL | Kimberly-Clark Corporation | 2012-05-11 | 179 | 0 |
| K110962 | AMBU ASCOPE 2 | Ambu A/S | 2011-11-18 | 226 | 0 |
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL | Well Lead Medical Co., Ltd. | 2011-08-26 | 211 | 2 |
| K100546 | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE | Parkermedicalinc | 2010-06-03 | 98 | 0 |
| K093186 | AMBU ASCOPE AND MONITOR | Ambu A/S | 2010-04-16 | 189 | 0 |
| K093135 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL T | Venner Medical (Singapore) Pte, Ltd. | 2010-04-02 | 179 | 0 |
| K091761 | TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SEC | Teleflexmedical, Inc. | 2009-10-29 | 135 | 15 |
| K090777 | EZC MEDICAL, LLC INTUBAIDFLEX | Ezc Medical, LLC | 2009-08-04 | 134 | 0 |
| K083119 | PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, | Smiths Medical Asd, Inc. | 2009-06-26 | 247 | 0 |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | Flexicare Medical, Ltd. | 2009-06-17 | 15 | 1 |
| K082038 | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V | Clarus Medical, LLC | 2009-04-28 | 285 | 0 |
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