510(k) Report

FDA applicant

Dyansys, Inc.

San Mateo, CA15 decisions2007–20220 recalls

FDA records 15 decisions for Dyansys, Inc. (San Mateo, CA) from 2007 to 2022: 15 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and NHI (Stimulator, Nerve, Electrical, Percutaneous…). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dyansys Corp”.

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

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

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

FDA decisions per year

4in 2022

2007: 22008: 12009: 22015: 12017: 12018: 12020: 12021: 22022: 4
2007high 4 (2022) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dyansys, 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?

  • DPSElectrocardiograph5decisions
  • NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief4decisions
  • PZRPercutaneous Nerve Stimulator For Opioid Withdrawal3decisions
  • BWKStimulator, Electro-Acupuncture2decisions
  • QHHNon-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 112 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 120 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 26 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 7 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.

  • K071168The Portable AnsiscopeDyansys, Inc. · 20074cite it
  • K072353Portable EcscopeDyansys Corp · 20073cite it
  • K080036Portable Ecscope 12IDyansys, Inc. · 20082cite it
  • K213188Primary ReliefDyansys, Inc. · 20221cites it
  • K211971Drug Relief v1Dyansys, Inc. · 20211cites it
  • K173861Drug ReliefDyansys, Inc. · 20181cites it

What has FDA decided for it lately?

  • K221425Primary ReliefDyansys, Inc. · 2022
  • K221231Drug Relief v1Dyansys, Inc. · 2022
  • K220397ANSiStim-PPDyansys, Inc. · 2022
  • K213188Primary ReliefDyansys, Inc. · 2022
  • K212859First ReliefDyansys, Inc. · 2021
  • K211971Drug Relief v1Dyansys, Inc. · 2021
  • K202940First Relief v1Dyansys, Inc. · 2020
  • K173861Drug ReliefDyansys, Inc. · 2018

All 14 as Dyansys, Inc. →The one decision as Dyansys Corp →