Cleared Traditional

K983800 - DN ACUPUNTURE NEEDLES

K983800 is an FDA 510(k) clearance for DN ACUPUNTURE NEEDLES, manufactured by Sedatelec. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K983800 · Sedatelec · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
303d
Days
Class 2
Risk

K983800 is an FDA 510(k) clearance for the DN ACUPUNTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Sedatelec (Pleasant Hill, US). The FDA issued a Cleared decision on August 27, 1999 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sedatelec devices

FDA 510(k) Submission Details - K983800

510(k) Number K983800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date August 27, 1999
Days to Decision 303 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
174d slower than avg
Panel avg: 129d · This submission: 303d
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 K983800.
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · Scientific Health Care · Jan 1998
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
K964861 · C.A.M. Supply, Inc. · May 1997
ACUPUNCTURE NEEDLES
K970574 · C.A.I. Industries Corp. · Apr 1997