Product code BTO— Anesthesiology
TRACHEOSTOMY CARE KIT
- Advisory panel
- Anesthesiology
- Total cleared
- 128
Adverse events under product code BTO
product code BTO- Death
- 14
- Injury
- 328
- Malfunction
- 1,851
- Total
- 2,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code BTO
1–100 of 128- K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
- K233713 — Pilling Tracheostomy Tubes
- K192511 — Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
- K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
- K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
- K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
- K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
- K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
- K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
- K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
- K073702 — PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
- K062104 — TALKING TRACH
- K060945 — PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
- K051587 — TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
- K050379 — CS MEDICAL ADULT TTCF CATHETER
- K042684 — WELL LEAD TRACHEOSTOMY TUBE
- K031553 — SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
- K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
- K030381 — PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
- K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
- K983000 — CRICOTHYROTOMY TUBE
- K981080 — SCOOP 1
- K955461 — TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
- K960205 — CPR TRACHEOTOMY CARE TRAY
- K962240 — MOORE TRACHEOSTOMY TUBE
- K953559 — LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
- K952416 — TRACHEOSTOMY CARE KIT
- K945406 — SSV PHONATE(TM) SHILEY SPEAKING VALVE
- K945407 — SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
- K941470 — TRACHEOSTOMY CARE KIT
- K924193 — TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
- K924191 — TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
- K924194 — TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
- K924195 — TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
- K923834 — TRACHEOSTOMY CARE SET WITH GLOVES
- K925249 — CMI STOMA COVERS
- K922749 — LOW PROFILE TRACHEOSTOMY TUBE
- K920281 — TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
- K921281 — TRACHEOSTOMY CARE KIT
- K920604 — BIVONA TRACHEAL T-TUBE STENT
- K914743 — EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
- K912124 — TRACHEOSTOMY TUBE AND CUFF
- K912469 — BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
- K903730 — D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
- K901920 — PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
- K902281 — MODIFIED SCOOP TRANSTRACHEAL CATHETERS
- K901078 — SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
- K901079 — SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
- K900548 — SHILEY PHONATION VALVE
- K894096 — STAT-TRACH(TM) VENTILATION CATHETER
- K896798 — TRACHEOSTOMY TRAY
- K895162 — TRAUMAFUSE TRACH SHIELD
- K895130 — HEIMLICH MICRO TRACH
- K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE
- K885139 — MODIFIED ADULT CRICOTHYROIDOTOMY KIT
- K890342 — AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
- K884730 — SHILEY PERC TRACHEOSTOMY SYSTEM
- K884015 — PREMIER DECANNULATION STOPPER
- K884427 — FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
- K882430 — HOOD TRACHEAL STOMA BUTTON
- K880614 — SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
- K874450 — SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
- K880316 — PREFILLED WATER FOR IRRIGATION USP
- K880317 — PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
- K880247 — MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
- K874742 — QUICKTRACH
- K873499 — TODD MEDICAL/SKILLED CARE PRODUCTS
- K872486 — LARKEL DEVICE W/ATTACHMENTS A-H
- K871199 — MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
- K870181 — JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
- K865061 — SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
- K862436 — TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
- K862909 — RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
- K862167 — MINI-TRACH KIT
- K862267 — FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
- K861645 — MICRO-TRACHEOSTOMY CARE KIT
- K853051 — TRACHEAL TUBES
- K855130 — TRACHEOSTOMY CARE KIT
- K854252 — TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
- K860176 — LARYNGECTOMY TUBE, CUFFED
- K853511 — THE HOOD LIFE SAVER
- K853419 — CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
- K852413 — LGT TUBE
- K852272 — BIVONA TRACHEOSTOMA VALVE II
- K851016 — PASSY-MUIR TRACH VALVE
- K851462 — BFW VOICE GENERATOR
- K850445 — TRACHEOSTOMY CARE TRAY
- K850446 — TRACHEOSTOMY CARE KIT
- K850456 — TRACHEOSTOMY CARE KIT
- K843785 — WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
- K843729 — SHILEY DISPOS. CANNULA FENESTRATED LOW
- K843730 — SHILEY DISPOS. DECANNULATION PLUG W/SW/
- K822440 — PERCUTANEOUS CRICOTHYROIDOTOMY
- K832466 — TRACHEAL TUBE 16 GAUGE-1.65MM-
- K842415 — ALL-HANDS TRACHEOSTOMY CARE SET 0101
- K841266 — MONTGOMERY TRACHEAL T-TUBE
- K840925 — PEDIA-TRAKE CRICOTHYROTOMY KIT
- K841546 — COMMUNI-TRACH TUBE
- K833832 — 3-DAY BIOINDICATOR RELEASE FOR RESPIR
- K840539 — DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
Data sourced from openFDA. This site is unofficial and independent of the FDA.