Cleared Traditional

K955030 - SQUARE ONE SAFETY SYRINGE

K955030 is an FDA 510(k) clearance for SQUARE ONE SAFETY SYRINGE, manufactured by Square One Medical, LP. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K955030 · Square One Medical, LP · General Hospital
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Dec 1995
Decision
43d
Days
Class 2
Risk

K955030 is an FDA 510(k) clearance for the SQUARE ONE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Square One Medical, LP (Camarillo, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 43 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.

View all Square One Medical, LP devices

FDA 510(k) Submission Details - K955030

510(k) Number K955030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1995
Decision Date December 15, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 122
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K955030.
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
K973301 · Retractable Technologies, Inc. · Nov 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
K970803 · Retractable Technologies, Inc. · May 1997
UNIVEC NON-REUSABLE SYRINGE
K933469 · Univec, Inc. · Apr 1996
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995