Cleared Traditional

K031594 - BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY

K031594 is an FDA 510(k) clearance for BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS..., manufactured by M.K. Meditech Co. , Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K031594 · M.K. Meditech Co. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
16d
Days
Class 2
Risk

K031594 is an FDA 510(k) clearance for the BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by M.K. Meditech Co. , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 16 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.

FDA 510(k) Submission Details - K031594

510(k) Number K031594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2003
Decision Date June 06, 2003
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K031594.
SAFEPRO PLUS SAFETY SYRINGE
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K031065 · Syringex Medical, Inc. · Jun 2003
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K030976 · Life-Shield Products, Inc. · May 2003
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
K031062 · Taiject Medical Device Co., Ltd. · May 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
K031594 · BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
Download PDF FDA Summary M.K. Meditech Co. , L…