Cleared Abbreviated

K080877 - 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2

K080877 is an FDA 510(k) clearance for 1ML UNITRACT INSULIN SYRINGE 27G*1/2, manufactured by Unilife Medical Solutions Limited. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 204-day FDA review.

K080877 · Unilife Medical Solutions Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
204d
Days
Class 2
Risk

K080877 is an FDA 510(k) clearance for the 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Unilife Medical Solutions Limited (Sydney, Nsw, AU). The FDA issued a Cleared decision on October 21, 2008 after a review of 204 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 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 - K080877

510(k) Number K080877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date October 21, 2008
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
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 K080877.
MED-LOK
K093176 · Sta-Med, LLC · Apr 2010
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K092430 · Inviro Medical Devices, Inc. · Sep 2009
ULTIMED ULTICARE SAFETY SYRINGE
K080600 · Ultimed, Inc. · Jun 2008
JIERUI SYRINGES AND NEEDLES
K072739 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2008
NEEDLE-TRAP/NEEDLE SAFETY LABEL
K073206 · Schreiner Medipharm · Jan 2008
K080877 · 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
Download PDF FDA Summary Unilife Medical Solut…