Cleared Special

K052075 - PROCEDUR-10

K052075 is an FDA 510(k) clearance for PROCEDUR-10, manufactured by Avanca Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 100-day FDA review.

K052075 · Avanca Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K052075

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
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 688
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K052075.
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
K060211 · Wenzhou Wuzhou Group Co. , Ltd. · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006
ARTSANA PISTON AND INSULIN SYRINGES
K052667 · Artsana S.P.A · Nov 2005
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173 · Orthovita, Inc. · Oct 2005
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
K052551 · Devon Safety Products, Inc. · Sep 2005
YI XIN STERILE SYRINGE FOR SINGLE USE
K050999 · Jiangxi Sanxin (Eversincere) Medical Devices Group · Sep 2005
K052075 · PROCEDUR-10
Download PDF FDA Summary Avanca Medical Device…