510(k) Report

FDA applicant

Helio Medical Supplies, Inc.

San Jose, CA12 decisions1996–20080 recalls

FDA records 12 decisions for Helio Medical Supplies, Inc. (San Jose, CA) from 1996 to 2008: 12 510(k) clearances. Most are in product codes MQX (Needle, Acupuncture, Single Use) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Helio Medical Supplies, 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?

  • MQXNeedle, Acupuncture, Single Use10decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 0 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.

  • K960036Firard II/ TDP LampHelio Medical Supplies, Inc. · 19964cite it
  • K961339Carbo Brand/Viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 19964cite it
  • K024207Vinco Brand Acupuncture NeedleHelio Medical Supplies, Inc. · 20032cite it
  • K991508Acumaster Brand Acupuncture NeedleHelio Medical Supplies, Inc. · 19991cites it
  • K043277C&G Acupuncture NeedleHelio Medical Supplies, Inc. · 20051cites it
  • K991507Kangnian Brand Acupuncture NeedleHelio Medical Supplies, Inc. · 19991cites it

What has FDA decided for it lately?

  • K080221EA StimulatorHelio Medical Supplies, Inc. · 2008
  • K072778Brio Acupuncture NeedlesHelio Medical Supplies, Inc. · 2007
  • K062448Lyra Acupuncture NeedlesHelio Medical Supplies, Inc. · 2006
  • K052723Seven Star NeedleHelio Medical Supplies, Inc. · 2006
  • K050295Press Tack/Intradermal Acupuncture NeedlesHelio Medical Supplies, Inc. · 2005
  • K043277C&G Acupuncture NeedleHelio Medical Supplies, Inc. · 2005
  • K024207Vinco Brand Acupuncture NeedleHelio Medical Supplies, Inc. · 2003
  • K012583Acuglide Brand Acupuncture NeedlesHelio Medical Supplies, Inc. · 2001

All 12 as Helio Medical Supplies, Inc. →