Cleared Traditional

K022278 - TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)

K022278 is an FDA 510(k) clearance for TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA1..., manufactured by Taiject Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K022278 · Taiject Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
59d
Days
Class 2
Risk

K022278 is an FDA 510(k) clearance for the TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Taiject Medical Device Co., Ltd. (Newport Beach, US). The FDA issued a Cleared decision on September 12, 2002 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Taiject Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K022278

510(k) Number K022278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2002
Decision Date September 12, 2002
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - MEG Syringe, Antistick

All 64
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K022278.
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · Aug 2006
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000
SUPERGUARD SAFETY SYRINGE
K990831 · U.S. Safety Syringes Co., Inc. · Mar 2000