510(k) Report

FDA applicant

Ultimed, Inc.

Minneapolis, MN10 decisions2000–20211 recall

FDA records 10 decisions for Ultimed, Inc. (Minneapolis, MN) from 2000 to 2021: 10 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Its devices cite 14 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ultimed Incorporated”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2021

2008: 22010: 12015: 12021: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ultimed, 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?

  • FMINeedle, Hypodermic, Single Lumen3decisions
  • FMFSyringe, Piston3decisions
  • MMKContainer, Sharps2decisions
  • MEGSyringe, Antistick2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K994230Ulticare Disposable SyringeUltimed, Inc. · 20002cite it
  • K080600Ultimed Ulticare Safety SyringeUltimed, Inc. · 20082cite it
  • K100812Ulticare Disposable Pen NeedlesUltimed, Inc. · 20102cite it
  • K213407UltiCare Disposable Pen NeedlesUltimed Incorporated · 20211cites it
  • K033794Ulticare Disposable Syringe 3 ML/CCUltimed, Inc. · 20031cites it
  • K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 20061cites it

What has FDA decided for it lately?

  • K213407UltiCare Disposable Pen NeedlesUltimed Incorporated · 2021
  • K140949Ulticare Safety Syringe with Removable NeedleUltimed Incorporated · 2015
  • K100812Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010
  • K080600Ultimed Ulticare Safety SyringeUltimed, Inc. · 2008
  • K081449Ultiguard Home Insulin Pen Needle Dispenser and Sharps ContainerUltimed, Inc. · 2008
  • K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 20061 recall
  • K050464Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2Ultimed, Inc. · 2005
  • K033794Ulticare Disposable Syringe 3 ML/CCUltimed, Inc. · 2003

All 8 as Ultimed, Inc. →All 2 as Ultimed Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062702Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes…Feb 5, 2010