Cleared Traditional

SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC (K070117) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070117 · Dolomite Biotech Sdn Bhd · General Hospital
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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.

View all Dolomite Biotech Sdn Bhd devices

Submission Details

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
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.

Device Classification

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
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