Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTO — Predicate Candidate Screening
128 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
270 days90th percentile
128clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy | Vitaltec Corporation | 2025-06-10 | 259 | 0 |
| K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024-03-22 | 123 | 0 |
| K192511 | Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner Pne | Venner Medical (Singapore) Pte, Ltd. | 2020-07-22 | 314 | 0 |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont | Smiths Medical Ads, Inc. | 2018-04-10 | 162 | 3 |
| K120079 | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) | Primed Halberstadt Medizintechnik GmbH | 2012-05-24 | 135 | 0 |
| K101721 | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Regulatory and Marketing Services, Inc. | 2011-03-24 | 279 | 0 |
| K100950 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | Venner Medical (Singapore) Pte, Ltd. | 2010-07-13 | 98 | 0 |
| K100480 | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH | Vitaltec Corporation | 2010-06-11 | 113 | 0 |
| K100283 | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CA | Cook, Inc. | 2010-04-23 | 81 | 0 |
| K083031 | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | Smiths Medical Asd, Inc. | 2009-08-18 | 312 | 0 |
| K073702 | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR C | Lazarus Medical, LLC | 2008-06-26 | 178 | 0 |
| K062104 | TALKING TRACH | Engineered Medical Systems, Inc. | 2007-04-20 | 270 | 0 |
| K060945 | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | Smiths Medical International | 2006-06-19 | 74 | 0 |
| K051587 | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: | Tracoe Medical GmbH | 2005-10-25 | 132 | 0 |
| K050379 | CS MEDICAL ADULT TTCF CATHETER | Cs Medical, Inc. | 2005-07-12 | 147 | 0 |
| K042684 | WELL LEAD TRACHEOSTOMY TUBE | Well Lead Medical Instruments | 2005-02-17 | 141 | 0 |
| K031553 | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEO | Arcadia Medical Corporation | 2003-11-18 | 183 | 2 |
| K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | Portex , Ltd. | 2003-09-17 | 205 | 0 |
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSA | Portex , Ltd. | 2003-08-27 | 203 | 1 |
| K021764 | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | Rusch Intl. | 2002-07-23 | 55 | 0 |
| K983000 | CRICOTHYROTOMY TUBE | Polamedco, Inc. | 1999-10-27 | 426 | 0 |
| K981080 | SCOOP 1 | Transtracheal Systems | 1998-06-17 | 85 | 0 |
| K955461 | TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). | VBM Medizintechnik GmbH | 1997-03-19 | 476 | 3 |
| K960205 | CPR TRACHEOTOMY CARE TRAY | Custom Pack Reliability | 1996-08-27 | 224 | 0 |
| K962240 | MOORE TRACHEOSTOMY TUBE | Boston Medical Products, Inc. | 1996-08-15 | 65 | 0 |
| K953559 | LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) | Seidel Medizin GmbH | 1996-05-16 | 331 | 0 |
| K952416 | TRACHEOSTOMY CARE KIT | Medi-Flex Hospital Products, Inc. | 1995-08-09 | 78 | 0 |
| K945406 | SSV PHONATE(TM) SHILEY SPEAKING VALVE | Mallinckrodt Medical Tpi, Inc. | 1995-02-27 | 116 | 0 |
| K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | Mallinckrodt Medical Tpi, Inc. | 1995-02-27 | 116 | 0 |
| K941470 | TRACHEOSTOMY CARE KIT | Clinical Resources, Inc. | 1995-02-14 | 323 | 0 |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | American Healthcare Corp. | 1993-06-16 | 300 | 0 |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | American Healthcare Corp. | 1993-04-02 | 225 | 0 |
| K924195 | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES | American Healthcare Corp. | 1993-01-06 | 139 | 0 |
| K924194 | TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) | American Healthcare Corp. | 1993-01-06 | 139 | 0 |
| K923834 | TRACHEOSTOMY CARE SET WITH GLOVES | American Healthcare Corp. | 1992-12-10 | 132 | 0 |
| K925249 | CMI STOMA COVERS | Community Medical Center | 1992-12-03 | 48 | 0 |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | Concord/Portex | 1992-09-02 | 86 | 3 |
| K920281 | TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-08-27 | 218 | 0 |
| K921281 | TRACHEOSTOMY CARE KIT | Trinity Laboratories, Inc. | 1992-08-27 | 163 | 0 |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Bivona Medical Technologies | 1992-07-27 | 167 | 0 |
| K914743 | EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF | Pertrach | 1992-07-10 | 273 | 0 |
| K912124 | TRACHEOSTOMY TUBE AND CUFF | Concord/Portex | 1991-08-16 | 95 | 0 |
| K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-06-19 | 15 | 44 |
| K903730 | D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES | Concord/Portex | 1990-09-25 | 40 | 0 |
| K901920 | PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE | Primecare, Inc. | 1990-08-17 | 109 | 0 |
| K902281 | MODIFIED SCOOP TRANSTRACHEAL CATHETERS | Transtracheal Systems | 1990-08-10 | 80 | 0 |
| K901079 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER | L H M Ent., Inc. | 1990-05-18 | 72 | 0 |
| K901078 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE | L H M Ent., Inc. | 1990-05-18 | 72 | 0 |
| K900548 | SHILEY PHONATION VALVE | Shiley, Inc. | 1990-04-23 | 77 | 0 |
| K894096 | STAT-TRACH(TM) VENTILATION CATHETER | Statron Corp. | 1990-03-16 | 280 | 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