Panels › Anesthesiology › Product code BTO · Class 2
Tube, Tracheostomy (W/Wo Connector)
Regulation 868.5800
1510(k)s in 12 months (129 all time)
1recalls in 12 months (73 all time)
69recalls that name a 510(k)
Top companies in BTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 55 |
| Shiley, Inc. | 13 | 0 |
| Bivona Medical Technologies | 6 | 0 |
| Nellcor Puritan Bennett Inc. (dba Covidien Ltd) | 0 | 6 |
| American Healthcare Corp. | 5 | 0 |
| Frederic J. Toye, M.D. | 5 | 0 |
| Hood Laboratories | 4 | 0 |
| Portex , Ltd. | 3 | 1 |
| Arcadia Medical Corporation | 1 | 2 |
| Boston Medical Products, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 1990 | K894096 | STAT-TRACH(TM) VENTILATION CATHETER Statron Corp. | BTO |
| Feb 22, 1990 | K896798 | TRACHEOSTOMY TRAY Westmark, Sterile Packing Systems, Inc. (Sps) | BTO |
| Jan 9, 1990 | K895162 | TRAUMAFUSE TRACH SHIELD The Traumafuse Co. | BTO |
| Nov 7, 1989 | K895130 | HEIMLICH MICRO TRACH Ballard Medical Products | BTO |
| Aug 7, 1989 | K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE Hood Laboratories | BTO |
| May 25, 1989 | K885139 | MODIFIED ADULT CRICOTHYROIDOTOMY KIT Pertrach | BTO |
| Apr 27, 1989 | K890342 | AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) Eastmed Enterprises, Inc. | BTO |
| Jan 17, 1989 | K884730 | SHILEY PERC TRACHEOSTOMY SYSTEM Shiley, Inc. | BTO |
| Nov 3, 1988 | K884015 | PREMIER DECANNULATION STOPPER Premier Dental | BTO |
| Nov 2, 1988 | K884427 | FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. Bivona Medical Technologies | BTO |
| Jun 28, 1988 | K882430 | HOOD TRACHEAL STOMA BUTTON Hood Laboratories | BTO |
| Mar 9, 1988 | K880614 | SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE Shiley, Inc. | BTO |
| Feb 29, 1988 | K880317 | PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP Automatic Liquid Packaging, Inc. | BTO |
| Feb 29, 1988 | K880316 | PREFILLED WATER FOR IRRIGATION USP Automatic Liquid Packaging, Inc. | BTO |
| Feb 29, 1988 | K874450 | SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT Surgitech C/O Collier, Shannon, Rill & Scott | BTO |
| Feb 12, 1988 | K880247 | MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES Shiley, Inc. | BTO |
| Dec 31, 1987 | K874742 | QUICKTRACH Posey Co. | BTO |
| Nov 24, 1987 | K873499 | TODD MEDICAL/SKILLED CARE PRODUCTS Todd Medical, Inc. | BTO |
| Sep 16, 1987 | K872486 | LARKEL DEVICE W/ATTACHMENTS A-H Seidel Medizin GmbH | BTO |
| Jun 8, 1987 | K871199 | MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. Frederic J. Toye, M.D. | BTO |
| May 14, 1987 | K870181 | JOHNSON INTRATRACHEAL OXYGEN CATHETER SET Cook, Inc. | BTO |
| Jan 15, 1987 | K865061 | SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE Shiley, Inc. | BTO |
| Nov 3, 1986 | K862436 | TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) Acutronic Medical Systems AG, CH | BTO |
| Sep 9, 1986 | K862909 | RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM Intl. Medical Devices , Ltd. | BTO |
| Aug 6, 1986 | K862167 | MINI-TRACH KIT Portex, Inc. | BTO |
| Jun 18, 1986 | K862267 | FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES Bivona Medical Technologies | BTO |
| May 9, 1986 | K861645 | MICRO-TRACHEOSTOMY CARE KIT Aci Medical, Inc. | BTO |
| Apr 11, 1986 | K853051 | TRACHEAL TUBES Erie Medical | BTO |
| Mar 4, 1986 | K855130 | TRACHEOSTOMY CARE KIT Dynarex Corp. | BTO |
| Feb 3, 1986 | K854252 | TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER Transtracheal Systems | BTO |
| Jan 27, 1986 | K860176 | LARYNGECTOMY TUBE, CUFFED Sheridan Catheter Corp. | BTO |
| Dec 19, 1985 | K853511 | THE HOOD LIFE SAVER Hood Laboratories | BTO |
| Dec 6, 1985 | K853419 | CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE Hood Laboratories | BTO |
| Sep 5, 1985 | K852413 | LGT TUBE Mallinckrodt Critical Care | BTO |
| Jul 8, 1985 | K852272 | BIVONA TRACHEOSTOMA VALVE II Bivona Medical Technologies | BTO |
| Jun 7, 1985 | K851016 | PASSY-MUIR TRACH VALVE Passy & Passy, Inc. | BTO |
| May 28, 1985 | K851462 | BFW VOICE GENERATOR Bfw Laboratories, Inc. | BTO |
| Mar 11, 1985 | K850456 | TRACHEOSTOMY CARE KIT Excel Health Care Products | BTO |
| Mar 11, 1985 | K850446 | TRACHEOSTOMY CARE KIT Paco Research Corp. | BTO |
| Mar 11, 1985 | K850445 | TRACHEOSTOMY CARE TRAY Paco Research Corp. | BTO |
| Oct 23, 1984 | K843785 | WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR Intl. Medical Devices , Ltd. | BTO |
| Oct 19, 1984 | K843730 | SHILEY DISPOS. DECANNULATION PLUG W/SW/ Shiley, Inc. | BTO |
| Oct 19, 1984 | K843729 | SHILEY DISPOS. CANNULA FENESTRATED LOW Shiley, Inc. | BTO |
| Oct 15, 1984 | K822440 | PERCUTANEOUS CRICOTHYROIDOTOMY Frederic J. Toye, M.D. | BTO |
| Sep 19, 1984 | K832466 | TRACHEAL TUBE 16 GAUGE-1.65MM- Erie Medical | BTO |
| Jul 6, 1984 | K842415 | ALL-HANDS TRACHEOSTOMY CARE SET 0101 All-Hands Medical Supply, Inc. | BTO |
| Jun 14, 1984 | K841266 | MONTGOMERY TRACHEAL T-TUBE E. Benson Hood Laboratories, Inc. | BTO |
| May 2, 1984 | K840925 | PEDIA-TRAKE CRICOTHYROTOMY KIT Intl. Medical Devices , Ltd. | BTO |
| Apr 30, 1984 | K841546 | COMMUNI-TRACH TUBE Implant Technology, Inc. | BTO |
| Mar 15, 1984 | K833832 | 3-DAY BIOINDICATOR RELEASE FOR RESPIR Shiley, Inc. | BTO |
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