Cleared Traditional

K031250 - DBC PRESS ACUPUNCTURE NEEDLES

K031250 is an FDA 510(k) clearance for DBC PRESS ACUPUNCTURE NEEDLES, manufactured by Lhasa Medical, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K031250 · Lhasa Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
87d
Days
Class 2
Risk

K031250 is an FDA 510(k) clearance for the DBC PRESS ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Lhasa Medical, Inc. (Weymouth, US). The FDA issued a Cleared decision on July 15, 2003 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5580 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031250

510(k) Number K031250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2003
Decision Date July 15, 2003
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQX Device Classification - Class 2, Special Controls

Product Code MQX Needle, Acupuncture, Single Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MQX Needle, Acupuncture, Single Use

All 90
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K031250.
ACUPUNCTURE NEEDLES
K041652 · C.A.I. Industries Corp. · Dec 2004
PRESS TACK NEEDLE
K042063 · Asia-Med GmbH & Co. Kg. - Werk Suhl · Oct 2004
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
K031818 · Facilai Enterprises , Ltd. · Dec 2003
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
K031060 · Lhasa Medical, Inc. · Jul 2003
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
K031716 · Asia-Med GmbH and CO KG · Jul 2003
VINCO BRAND ACUPUNCTURE NEEDLE
K024207 · Helio Medical Supplies, Inc. · Apr 2003
K031250 · DBC PRESS ACUPUNCTURE NEEDLES
Download PDF FDA Summary Lhasa Medical, Inc.