Cleared Special

PROCEDUR-10 (K052075) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052075 · Avanca Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
100d
Days
Class 2
Risk

K052075 is an FDA 510(k) clearance for the PROCEDUR-10. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Avanca Medical Devices, Inc. (Albuquerque, US). The FDA issued a Cleared decision on November 9, 2005 after a review of 100 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. 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.

View all Avanca Medical Devices, Inc. devices

Submission Details

510(k) Number K052075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date November 09, 2005
Days to Decision 100 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 226
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K052075.
MEDLINE SYRINGES, MULTIPLE
K061275 · Medline Industries, Inc. · Jul 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004