Cleared Special

K093400 - 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2

K093400 is an FDA 510(k) clearance for 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 ..., manufactured by Unilife Medical Solutions Limited. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 150-day FDA review.

K093400 · Unilife Medical Solutions Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
150d
Days
Class 2
Risk

K093400 is an FDA 510(k) clearance for the 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Unilife Medical Solutions Limited (Lewisberry, US). The FDA issued a Cleared decision on April 1, 2010 after a review of 150 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093400

510(k) Number K093400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2009
Decision Date April 01, 2010
Days to Decision 150 days
Submission Type Special
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
21d slower than avg
Panel avg: 129d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 634
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K093400.
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EPIDRUM
K093863 · Exmoor Plastics , Ltd. · May 2010
COAXIAL APPLICATOR SYSTEM
K091722 · Biomet, Inc. · Mar 2010
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO
K092908 · Neomed, Inc. · Mar 2010
ACACIA PISTON SYRINGE
K092986 · Acacia, Inc. · Oct 2009
K093400 · 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2
Download PDF FDA Summary Unilife Medical Solut…