Cleared Traditional

K030190 - CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES

K030190 is an FDA 510(k) clearance for CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES, manufactured by Suzhou Sen Sen Medical Supplies , Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K030190 · Suzhou Sen Sen Medical Supplies , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
31d
Days
Class 2
Risk

K030190 is an FDA 510(k) clearance for the CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Suzhou Sen Sen Medical Supplies , Ltd. (Ontario, CA). The FDA issued a Cleared decision on February 21, 2003 after a review of 31 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.

View all Suzhou Sen Sen Medical Supplies , Ltd. devices

FDA 510(k) Submission Details - K030190

510(k) Number K030190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date February 21, 2003
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
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 43
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K030190.
SMC ACUPUNCTURE NEEDLE
K141473 · Smc Intl., Inc. · Aug 2014
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
K132896 · Asia-Med GmbH and CO KG · Dec 2013
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
K111392 · Woojeon Company · Nov 2011
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · Sedatelec · Aug 1999
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · Helio Medical Supplies, Inc. · Aug 1999