510(k) Report

FDA applicant

Neometrics, Inc.

Plymouth, MN21 decisions1978–20151 recall

FDA records 21 decisions for Neometrics, Inc. (Plymouth, MN) from 1978 to 2015: 21 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and OCY (Endoscopic Guidewire, Gastroenterology-Urology). Its devices cite 22 predicates, 12 of them its own earlier devices. 1 recall is linked to its devices.

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

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

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

FDA decisions per year

3in 2015

2007: 12010: 12013: 12014: 12015: 3
2007high 3 (2015) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • DQXWire, Guide, Catheter9decisions
  • OCYEndoscopic Guidewire, Gastroenterology-Urology3decisions
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone2decisions
  • CDXRadioimmunoassay, Total Thyroxine2decisions
  • MMXDevice, Percutaneous Retrieval1decision
  • JLXRadioimmunoassay, 17-Hydroxyprogesterone1decision

Also: JNB (1), JIA (1), KLI (1).

Whose devices does it build on?

Its devices cite 22 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 12 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.

  • K013024Selectiva GuidewireNeometrics, Inc. · 20014cite it
  • K031652Vascupuncture Picc GuidewireNeometrics, Inc. · 20033cite it
  • K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 20042cite it
  • K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 20052cite it
  • K033321Selectiva SB GuidewireNeometrics, Inc. · 20031cites it
  • K012861Vascupuncture Access WireNeometrics, Inc. · 20021cites it

What has FDA decided for it lately?

  • K152560Bard Snare Retrieval KitNeometrics, Inc. · 2015
  • K150225NovaGold High Performance GuidewireNeometrics, Inc. · 2015
  • K143135Spring Coil GuidewireNeometrics, Inc. · 2015
  • K133076Novagold High Performance GuidewireNeometrics, Inc. · 20141 recall
  • K123439Neo Ercp GuidewireNeometrics, Inc. · 2013
  • K101729Neowire Pta/Ptca GuidewireNeometrics, Inc. · 2010
  • K070150Vascupuncture Picc GuidewireNeometrics, Inc. · 2007
  • K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005

All 21 as Neometrics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K133076Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using…Mar 31, 2014Class II