Company ยท US
Sims Portex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2002. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 5 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 |
| MQE | Needle, Assisted Reproduction | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FRN | Pump, Infusion | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 |
| HHW | Pessary, Vaginal | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| MIA | Needle, Spinal, Short Term | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2002 | K012277 | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE Sims Portex , Ltd., GB | HHW |
| Aug 3, 2001 | K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S Sims Portex , Ltd., GB | MQE |
| Jul 12, 2001 | K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO Sims Portex, Inc. | FMI |
| Feb 5, 2001 | K002201 | ELECTROSTATIC HYDROPHOBIC BREATHING FILTER Sims Portex, Inc. | CAH |
| Dec 14, 2000 | K002506 | BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT Sims Portex, Inc. | CAH |
| Aug 2, 2000 | K001555 | SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 Sims Portex , Ltd., GB | HHK |
| Jul 20, 2000 | K001318 | CPAP SYSTEM, MODEL 102001 Sims Portex, Inc. | BYE |
| Apr 28, 2000 | K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK Sims Portex, Inc. | BSP |
| Mar 13, 2000 | K000628 | WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 Sims Portex , Ltd., GB | MQE |
| Feb 22, 2000 | K994275 | SIMS PORTEX ANESTHESIA CATHETER Sims Portex, Inc. | FRN |
| Jan 18, 2000 | K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE Sims Portex, Inc. | BTM |
| Oct 22, 1999 | K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 Sims Portex, Inc. | BSO |
| Sep 13, 1999 | K992057 | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 Sims Portex, Inc. | BTM |
| Jan 29, 1999 | K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES Sims Portex, Inc. | MIA |
| Apr 21, 1998 | K981035 | PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES Sims Portex, Inc. | JKA |
| Feb 24, 1998 | K980466 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA Sims Portex, Inc. | JOH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8506P Terminated |
BTM | K014115 |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8503P Terminated |
BTM | K014115 |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8500P Terminated |
BTM | K014115 |