510(k) Report

FDA applicant

Prime Herbs Corporation

San Jose, CA2 decisions2006–20090 recalls

FDA records 2 decisions for Prime Herbs Corporation (San Jose, CA) from 2006 to 2009: 2 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and MQX (Needle, Acupuncture, Single Use). Its devices cite 4 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, physical medicine panel, where it files most

How often FDA has decided Prime Herbs Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prime Herbs Corporation 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?

  • ILYLamp, Infrared, Therapeutic Heating1decision
  • MQXNeedle, Acupuncture, Single Use1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K081720Precision TDP, Heat and Infrared Lamps and Marvel and Wonder LampsPrime Herbs Corporation · 20091cites it

What has FDA decided for it lately?

  • K081720Precision TDP, Heat and Infrared Lamps and Marvel and Wonder LampsPrime Herbs Corporation · 2009
  • K061517Precision Press Tack / Intraderm, Seven Star and Acupuncture Needles; Alpha and Fine Point Acupuncture NeedlesPrime Herbs Corporation · 2006

All 2 as Prime Herbs Corporation →

Other applicant names beginning “Prime”

FDA records each applicant name separately; these may or may not be the same firm.

Prime Dental Manufacturing, Inc. 9Prime Pacific Health Innovations Corporation 2Prime Medical Products, Inc. 2Prime Horizon, Inc. 1Prime Ideas, Inc. 1Prime Merit Intl. Corp. 1Prime Engineering 1