Company ยท US
Portex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2004. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 4 |
| CAZ | Anesthesia Conduction Kit | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 |
| JOH | Tube Tracheostomy And Tube Cuff | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| FMF | Syringe, Piston | 1 |
| FMH | Container, Specimen, Sterile | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| KAC | Tube, Laryngectomy | 1 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 1 |
| MQE | Needle, Assisted Reproduction | 1 |
| MQF | Catheter, Assisted Reproduction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2004 | K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER Portex, Inc. | CAZ |
| Feb 13, 2004 | K040014 | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY Portex , Ltd., GB | JOH |
| Jan 26, 2004 | K032112 | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) Portex , Ltd., GB | BTR |
| Dec 19, 2003 | K033084 | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER Portex , Ltd., GB | MQF |
| Nov 28, 2003 | K032716 | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) Portex , Ltd., GB | CAH |
| Sep 17, 2003 | K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE Portex , Ltd., GB | BTO |
| Aug 27, 2003 | K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA Portex , Ltd., GB | BTO |
| Jul 18, 2003 | K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT Portex, Inc. | JOH |
| Jun 26, 2003 | K031622 | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS Portex , Ltd., GB | MQE |
| Feb 11, 2003 | K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR Portex, Inc. | BTM |
| Feb 27, 2002 | K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX Portex, Inc. | BTM |
| Feb 13, 2002 | K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE Portex, Inc. | FMF |
| Mar 24, 1988 | K873992 | LARYNGECTOMY TUBE Portex, Inc. | KAC |
| Jan 19, 1988 | K874597 | THERMOVENT 600, 1200, T, 02 Portex, Inc. | BYD |
| Aug 6, 1986 | K862167 | MINI-TRACH KIT Portex, Inc. | BTO |
| Jul 6, 1984 | K842456 | JET VENTILATION ADAPTOR Portex, Inc. | |
| Feb 4, 1984 | K833908 | IRRI-CATH Portex, Inc. | BSY |
| Jan 17, 1984 | K840015 | SWIVEL ADAPTOR W/ALARM PORT Portex, Inc. | BZA |
| Jan 17, 1984 | K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE Portex, Inc. | BTS |
| Nov 28, 1983 | K833189 | HYDROFLOW SUCTION IRRIGATION SYSTEM Portex, Inc. | GCJ |
| Aug 12, 1983 | K830716 | CARDIO-ESOPHASCOPE Portex, Inc. | BZT |
| Mar 8, 1983 | K830352 | REINFORCED SILICONE TRACHEAL TUBE Portex, Inc. | BTR |
| Feb 5, 1981 | K810147 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE Portex, Inc. | BZT |
| Sep 9, 1980 | K802065 | CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG Portex, Inc. | BSO |
| Nov 20, 1979 | K792202 | TROCAR CATHETER/THORACIC CATHETER Portex, Inc. | DWF |
| Aug 2, 1978 | K781052 | CONTINUOUS EPIDURAL ANESTHESIA TRAY Portex, Inc. | CAZ |
| Mar 14, 1977 | K770112 | SPECIMEN COLLECTOR Portex, Inc. | FMH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2003 | Portex Inc Portex Spinal Tray with 25G Whitacre Needle.
Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine
Catalog Number: 15545-20 Terminated |
CAZ | K965017 |
| Jul 23, 2003 | Portex Inc. Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm
Catalog Number: 593090 Terminated |
BTO | K922749 |
| Jul 19, 2003 | Portex Ltd. Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear Murphy Eye
8 mm x 33cm
Reference Number: 100/199/080 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal
5 mmx 25cm
Reference Number: 100/179/050 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised
5 mm x 25cm
Reference Number: 100/141/050 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear
3.5 mm x 19cm
Reference Number: 100/127/035 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Oral Tracheal Tubes, Siliconized
6mm x 19cm
Reference Number: 100/126/060 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised
8mm x 33cm
Reference Number: 100/111/080 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised
3.5mm x 19cm
Reference Number: 100/111/035 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised
3mm x 17cm
Reference Number: 100/111/030 Terminated |
None listed | |
| Jul 19, 2003 | Portex Ltd. Portex Uncuffed Nasal Tracheal Tubes, Ivory
5mm x 25cm
Reference Number: 100/105/050 Terminated |
None listed | |
| Jun 12, 2003 | Portex, Inc Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40. Terminated |
KOH | K894613 K894614 +1 |