510(k) Report

FDA applicant

Sims Portex, Inc.

Keene, NH16 decisions1998–20024 recalls

FDA records 16 decisions for Sims Portex, Inc. (Keene, NH) from 1998 to 2002: 16 510(k) clearances. Most are in product codes MQE (Needle, Assisted Reproduction) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 10 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Sims Portex , Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Sims Portex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sims Portex, Inc. since 2007.

Recalls per year

1in 2018

2008: 12018: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sims Portex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sims Portex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQENeedle, Assisted Reproduction2decisions
  • BTMVentilator, Emergency, Manual (Resuscitator)2decisions
  • CAHFilter, Bacterial, Breathing-Circuit2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision
  • HHWPessary, Vaginal1decision

Also: JOH (1), MIA (1), HHK (1), JKA (1), BSO (1), FRN (1).

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K980466Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner CannulaSims Portex, Inc. · 19984cite it
  • K992471Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18Sims Portex, Inc. · 19993cite it
  • K002201Electrostatic Hydrophobic Breathing FilterSims Portex, Inc. · 20013cite it
  • K011925Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with…Sims Portex, Inc. · 20012cite it
  • K983858Spinal Anesthesia Needles and Introducer NeedlesSims Portex, Inc. · 19992cite it
  • K012068Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733SSims Portex, Ltd. · 20011cites it

What has FDA decided for it lately?

  • K012277Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non SterileSims Portex, Ltd. · 2002
  • K012068Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733SSims Portex, Ltd. · 20011 recall
  • K011925Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with…Sims Portex, Inc. · 20011 recall
  • K002201Electrostatic Hydrophobic Breathing FilterSims Portex, Inc. · 2001
  • K002506Breathing Filter for Disposable Anesthesia Breathing CircuitSims Portex, Inc. · 2000
  • K001555Suresample-Wallace Endometrial Sampler, Endo 26Sims Portex, Ltd. · 2000
  • K001318Cpap System, Model 102001Sims Portex, Inc. · 2000
  • K993619Csecure Combined Spinal/Epidural Anesthesia System with LockSims Portex, Inc. · 2000

All 12 as Sims Portex, Inc. →All 4 as Sims Portex, Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K981035Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and…Jul 13, 2018Class III
  • K000628Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing…Oct 23, 2008
  • K011925Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2''…Jun 29, 2004
  • K980466PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF #…Dec 12, 2003

Other applicant names beginning “Sims”

FDA records each applicant name separately; these may or may not be the same firm.

Sims Deltec, Inc. 32Sims Surgical, Inc. 3Sims Level 1, Inc. 2Sims 2