Cleared Traditional

K003555 - SOLO-SAFE SAFETY SYRINGE, SIZE-3CC

K003555 is an FDA 510(k) clearance for SOLO-SAFE SAFETY SYRINGE, manufactured by Spectrum Biotech, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K003555 · Spectrum Biotech, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
285d
Days
Class 2
Risk

K003555 is an FDA 510(k) clearance for the SOLO-SAFE SAFETY SYRINGE, SIZE-3CC. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Spectrum Biotech, Inc. (N.Vancouver, British Columbia, CA). The FDA issued a Cleared decision on August 29, 2001 after a review of 285 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 - K003555

510(k) Number K003555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date August 29, 2001
Days to Decision 285 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
156d slower than avg
Panel avg: 129d · This submission: 285d
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 K003555.
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · Safegard Medical Products, Inc. · Oct 2001
PROSAFE SAFETY SYRINGE
K012726 · Hou-Se Medical, Inc. · Oct 2001
AUTO-LOCK
K010477 · Auto-Lock · Oct 2001
BD SPRING BASED SYRINGE
K011103 · Bd · Jun 2001
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
K011369 · Safety Syringes, Inc. · May 2001
E.N.S.I. RETRACTABLE SAFETY SYRINGE
K003348 · Ensi-Med International Pty. , Ltd. · Jan 2001
K003555 · SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
Download PDF FDA Summary Spectrum Biotech, Inc.