510(k) Report

FDA applicant

Spintech, Inc.

Washington, DC12 decisions1992–20220 recalls

FDA records 12 decisions for Spintech, Inc. (Washington, DC) from 1992 to 2022: 12 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and EJI (Syringe, Cartridge). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spintech, LLC”.

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

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

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

FDA decisions per year

1in 2022

2018: 12021: 32022: 1
2007high 3 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spintech, 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging3decisions
  • EJISyringe, Cartridge3decisions
  • FMFSyringe, Piston2decisions
  • FXXMask, Surgical2decisions
  • KWPAppliance, Fixation, Spinal Interlaminal1decision
  • EFBHandpiece, Air-Powered, Dental1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 128 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K173224Spin-SwiSpintech, Inc. · 20182cite it
  • K961648The WandSpintech, Inc. · 19962cite it
  • K992819Wand PlusSpintech, Inc. · 20001cites it
  • K210843STAGESpintech, Inc. · 20211cites it

What has FDA decided for it lately?

  • K223079StageSpintech, Inc. · 2022
  • K212109Spin Care Disposable Protective Mask Level 3Spintech, LLC · 2021
  • K210843STAGESpintech, Inc. · 2021
  • K201624Spin Care Disposable Protective MaskSpintech, LLC · 2021
  • K173224Spin-SwiSpintech, Inc. · 2018
  • K023722Safetywand Disposable HandpieceSpintech, Inc. · 2003
  • K010692The Wand Plus Computer Controlled Anesthetic Delivery SystemSpintech, Inc. · 2001
  • K992404The WandSpintech, Inc. · 2000

All 10 as Spintech, Inc. →All 2 as Spintech, LLC →