Cleared Traditional

K970254 - SEIRIN PYONEX ACUPUNCTURE NEEDLES

K970254 is an FDA 510(k) clearance for SEIRIN PYONEX 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 19-day FDA review.

K970254 · Seirin-America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
19d
Days
Class 2
Risk

K970254 is an FDA 510(k) clearance for the SEIRIN PYONEX 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 February 10, 1997 after a review of 19 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 - K970254

510(k) Number K970254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1997
Decision Date February 10, 1997
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 11
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K970254.
DONG BANG ACUPUNCTURE NEEDLES
K972659 · Dong Bang, U.S.A. · Oct 1997
ACUPUNCTURE NEEDLES
K964861 · C.A.M. Supply, Inc. · May 1997
ACUPUNCTURE NEEDLES
K970574 · C.A.I. Industries Corp. · Apr 1997
SEIRIN JR ACUPUNCTURE NEEDLES
K970260 · Seirin-America, Inc. · Feb 1997
CW ACUPUNCTURE NEEDLES
K964529 · Lhasa Medical, Inc. · Jan 1997
TAKI ACUPUNCTURE NEEDLES
K964411 · Lhasa Medical, Inc. · Dec 1996