Cleared Special

K031062 - TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)

K031062 is an FDA 510(k) clearance for TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML..., manufactured by Taiject Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 29-day FDA review.

K031062 · Taiject Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
29d
Days
Class 2
Risk

K031062 is an FDA 510(k) clearance for the TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES.... 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 May 2, 2003 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 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031062

510(k) Number K031062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date May 02, 2003
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K031062.
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
K031065 · Syringex Medical, Inc. · Jun 2003
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
K031594 · M.K. Meditech Co. , Ltd. · Jun 2003
CAREO RETRACTABLE SAFETY SYRINGE
K030976 · Life-Shield Products, Inc. · May 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
EXEL SECURETOUCH PTP SYRINGE
K011754 · Exelint Intl. Co. · Jan 2003
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
K023458 · Taiject Medical Device Co., Ltd. · Nov 2002
K031062 · TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
Download PDF FDA Summary Taiject Medical Devic…