Cleared Traditional

K964861 - ACUPUNCTURE NEEDLES

K964861 is an FDA 510(k) clearance for ACUPUNCTURE NEEDLES, manufactured by C.A.M. Supply, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K964861 · C.A.M. Supply, Inc. · General Hospital
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May 1997
Decision
176d
Days
Class 2
Risk

K964861 is an FDA 510(k) clearance for the ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by C.A.M. Supply, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 29, 1997 after a review of 176 days - an extended review 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: 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.

View all C.A.M. Supply, Inc. devices

FDA 510(k) Submission Details - K964861

510(k) Number K964861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date May 29, 1997
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 129d · This submission: 176d
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 K964861.
KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE
K974527 · American Institute of Koryo Hand Therapy · Jan 1998
MAGI ACUPUNCTURE NEEDLES
K972658 · Dong Bang, U.S.A. · Oct 1997
DONG BANG ACUPUNCTURE NEEDLES
K972659 · Dong Bang, U.S.A. · Oct 1997
ACUPUNCTURE NEEDLES
K970574 · C.A.I. Industries Corp. · Apr 1997
SEIRIN PYONEX ACUPUNCTURE NEEDLES
K970254 · Seirin-America, Inc. · Feb 1997
SEIRIN JR ACUPUNCTURE NEEDLES
K970260 · Seirin-America, Inc. · Feb 1997