510(k) Report

FDA applicant

Asia-Med GmbH and CO KG

Littleton, CO4 decisions2001–20130 recalls

FDA records 4 decisions for Asia-Med GmbH and CO KG (Littleton, CO) from 2001 to 2013: 4 510(k) clearances. All are in product code MQX (Needle, Acupuncture, Single Use). 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 Asia-Med GmbH and CO KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Asia-Med GmbH and CO KG 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 Use4decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K052085Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture NeedlesAsia-Med GmbH and CO KG · 20052cite it
  • K031716Special+, S-Needle J-Type, S-Needle B-TypeAsia-Med GmbH and CO KG · 20031cites it

What has FDA decided for it lately?

  • K132896CJ-Type: Metal Handle with Guide Tube, PJ-Type: Plastic Handle with Guide Tube, CB-Type: Metal Handle…Asia-Med GmbH and CO KG · 2013
  • K052085Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture NeedlesAsia-Med GmbH and CO KG · 2005
  • K031716Special+, S-Needle J-Type, S-Needle B-TypeAsia-Med GmbH and CO KG · 2003
  • K011808Asia-Med Acupuncture Needles, (Standard, Special, Compact, Apex)Asia-Med GmbH and CO KG · 2001

All 4 as Asia-Med GmbH and CO KG →