510(k) Report

FDA applicant

Sedatelec

Pleasant Hill, CA4 decisions1999–20100 recalls

FDA records 4 decisions for Sedatelec (Pleasant Hill, CA) from 1999 to 2010: 4 510(k) clearances. Most are in product codes MQX (Needle, Acupuncture, Single Use) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 2 predicates, 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 Sedatelec’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MQXNeedle, Acupuncture, Single Use3decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K983800DN Acupunture NeedlesSedatelec · 19991cites it

What has FDA decided for it lately?

  • K101267Premio 10 MoxaSedatelec · 2010
  • K060392Asp TitaniumSedatelec · 2006
  • K983798Sedatelec Asp Acupuncture NeedlesSedatelec · 1999
  • K983800DN Acupunture NeedlesSedatelec · 1999

All 4 as Sedatelec →