Cleared Traditional

K062702 - ULTICARE DISPOSABLE SYRINGES AND NEEDLES

K062702 is an FDA 510(k) clearance for ULTICARE DISPOSABLE SYRINGES AND NEEDLES, manufactured by Ultimed, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K062702 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
79d
Days
Class 2
Risk

K062702 is an FDA 510(k) clearance for the ULTICARE DISPOSABLE SYRINGES AND NEEDLES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ultimed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 29, 2006 after a review of 79 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 Ultimed, Inc. devices

FDA 510(k) Submission Details - K062702

510(k) Number K062702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2006
Decision Date November 29, 2006
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 372
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K062702.
AUTO-FILL SYRINGE KIT, MODEL 7600
K063851 · Vascular Solutions, Inc. · Jan 2007
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613 · Terumo Medical Corp. · Dec 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · Medtronic Sofamor Danek USA, Inc. · Dec 2006
INJEKT SYRINGE
K063280 · B.Braun Medical, Inc. · Nov 2006
ARTHREX ASPIRATE KIT
K062365 · Arthrex, Inc. · Sep 2006
BAXTER DUPLOSPRAY MIS APPLICATOR
K061092 · Micromedics, Inc. · Sep 2006