# Sims Portex, Inc.

- Location (FDA's records): Keene, NH
- FDA decisions: 16 (1998–2002): 16 510(k) clearances
- Names in FDA's records: Sims Portex, Inc. (12); Sims Portex , Ltd. (4)
- Product codes: MQE (2), BTM (2), CAH (2), FMI (1), BSP (1), HHW (1), JOH (1), MIA (1), HHK (1), JKA (1), BSO (1), FRN (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 18 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smiths Industries Medical Systems, Inc.: 2 (https://510kreport.com/company/smiths-industries-medical-systems)
- Pajunk GmbH: 2 (https://510kreport.com/company/pajunk)
- Concord/Portex: 1 (https://510kreport.com/company/concord-portex)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Deschutes Medical Products, Inc.: 1 (https://510kreport.com/company/deschutes-medical-products)
- Preferred Medical Products: 1 (https://510kreport.com/company/preferred-medical-products)
- Burron Medical Products, Inc.: 1 (https://510kreport.com/company/burron-medical-products)

## Firms that cite its devices most
- Portex, Inc.: 6 (https://510kreport.com/company/portex)
- Smiths Medical Asd, Inc.: 3 (https://510kreport.com/company/smiths-medical-asd)
- Engineered Medical Systems: 2 (https://510kreport.com/company/engineered-medical-systems)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Zhejiang Kindly Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-kindly-medical-devices)
- Pneumrx, Inc.: 1 (https://510kreport.com/company/pneumrx)
- Smiths Medical: 1 (https://510kreport.com/company/smiths-medical)
- Air Safety, Ltd.: 1 (https://510kreport.com/company/air-safety)

## Its most-cited devices
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula (1998), cited by 4
- K992471: Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18 (1999), cited by 3
- K002201: Electrostatic Hydrophobic Breathing Filter (2001), cited by 3
- K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio (2001), cited by 2
- K983858: Spinal Anesthesia Needles and Introducer Needles (1999), cited by 2
- K012068: Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S (2001), cited by 1

## Recent decisions
- K012277: Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile (Feb 11, 2002)
- K012068: Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S (Aug 3, 2001)
- K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio (Jul 12, 2001)
- K002201: Electrostatic Hydrophobic Breathing Filter (Feb 5, 2001)
- K002506: Breathing Filter for Disposable Anesthesia Breathing Circuit (Dec 14, 2000)
- K001555: Suresample-Wallace Endometrial Sampler, Endo 26 (Aug 2, 2000)
- K001318: Cpap System, Model 102001 (Jul 20, 2000)
- K993619: Csecure Combined Spinal/Epidural Anesthesia System with Lock (Apr 28, 2000)

Source page: https://510kreport.com/company/sims-portex