Cleared Traditional

K070117 - SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC

K070117 is an FDA 510(k) clearance for SSAFE PLUS DISPOSABLE SAFETY SYRINGE, manufactured by Dolomite Biotech Sdn Bhd. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K070117 · Dolomite Biotech Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
206d
Days
Class 2
Risk

K070117 is an FDA 510(k) clearance for the SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Dolomite Biotech Sdn Bhd (San Leandro, US). The FDA issued a Cleared decision on August 6, 2007 after a review of 206 days - an extended review 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: 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.

FDA 510(k) Submission Details - K070117

510(k) Number K070117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2007
Decision Date August 06, 2007
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
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 K070117.
NEEDLE-TRAP/NEEDLE SAFETY LABEL
K073206 · Schreiner Medipharm · Jan 2008
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K072037 · Life-Shield Products, Inc. · Aug 2007
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
K070203 · Inviro Medical Devices, Inc. · Apr 2007
SAF-T-SYRINGE- 0.5 AND 1ML/CC
K063340 · Safety Medical International, Incorporated · Mar 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
K070117 · SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
Download PDF FDA Summary Dolomite Biotech Sdn …