Cleared Abbreviated

K000860 - FUTURA SAFETY SYRINGE

K000860 is an FDA 510(k) clearance for FUTURA SAFETY SYRINGE, manufactured by Sheila W. Pickering. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K000860 · Sheila W. Pickering · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
105d
Days
Class 2
Risk

K000860 is an FDA 510(k) clearance for the FUTURA SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Sheila W. Pickering (Los Altos, US). The FDA issued a Cleared decision on June 30, 2000 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K000860

510(k) Number K000860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2000
Decision Date June 30, 2000
Days to Decision 105 days
Submission Type Abbreviated
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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

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 K000860.
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
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · Retrax Safety Systems, Inc. · Jun 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000
SUPERGUARD SAFETY SYRINGE
K990831 · U.S. Safety Syringes Co., Inc. · Mar 2000
K000860 · FUTURA SAFETY SYRINGE
Download PDF FDA Summary Sheila W. Pickering