Cleared Traditional

K962809 - SEIRIN ACUPUNCTURE NEEDLES

K962809 is an FDA 510(k) clearance for SEIRIN ACUPUNCTURE NEEDLES, manufactured by Seirin-America, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K962809 · Seirin-America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
29d
Days
Class 2
Risk

K962809 is an FDA 510(k) clearance for the SEIRIN ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Seirin-America, Inc. (Weymouth, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 29 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 Seirin-America, Inc. devices

FDA 510(k) Submission Details - K962809

510(k) Number K962809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date August 16, 1996
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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.