Cleared Traditional

K062865 - SMALL VOLUME SYRINGE

K062865 is the FDA 510(k) clearance for SMALL VOLUME SYRINGE by Alcon Laboratories. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K062865 · Alcon Laboratories · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
332d
Days
Class 2
Risk

K062865 is an FDA 510(k) clearance for the SMALL VOLUME SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on August 23, 2007 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Alcon Laboratories devices

Submission Details

510(k) Number K062865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date August 23, 2007
Days to Decision 332 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
203d slower than avg
Panel avg: 129d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 280
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K062865.
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007
GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007