Cleared Traditional

K012501 - H.M.T. ACUPUNCTURE NEEDLE

K012501 is an FDA 510(k) clearance for H.M.T. ACUPUNCTURE NEEDLE, manufactured by Hummingbird Medical Technology, LLC. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K012501 · Hummingbird Medical Technology, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
130d
Days
Class 2
Risk

K012501 is an FDA 510(k) clearance for the H.M.T. ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Hummingbird Medical Technology, LLC (Allen, US). The FDA issued a Cleared decision on December 11, 2001 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K012501

510(k) Number K012501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date December 11, 2001
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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 K012501.
QIZHOU ACUPUNCTURE NEEDLE
K013926 · Wujiang City Shenli Medical and Health Material CO · Jul 2002
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
K020880 · Marknew Products · Jun 2002
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
K021095 · Wujiang City Hua Xin Medical Appliance Co., Ltd. · May 2002
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
K012583 · Helio Medical Supplies, Inc. · Dec 2001
CW DISPOSABLE ACUPUNCTURE NEEDLE
K011248 · Acusupply, Inc. · Oct 2001
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011247 · Acusupply, Inc. · Oct 2001
K012501 · H.M.T. ACUPUNCTURE NEEDLE
Download PDF FDA Summary Hummingbird Medical T…