Cleared Special

K053120 - STERILE FIELD SALINE AND HEPARIN LOCK F...

K053120 is the FDA 510(k) clearance for STERILE FIELD SALINE AND HEPARIN LOCK F... by Excelsior Medical Corp.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Special 510(k) pathway after a 32-day FDA review.

K053120 · Excelsior Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
32d
Days
Class 2
Risk

K053120 is an FDA 510(k) clearance for the STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Excelsior Medical Corp. (Neptune, US). The FDA issued a Cleared decision on December 9, 2005 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Excelsior Medical Corp. devices

Submission Details

510(k) Number K053120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2005
Decision Date December 09, 2005
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 142
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K053120.
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690 · Cook, Inc. · Jul 2008
SHERLOCK TIP LOCATION SYSTEM (TLS)
K060341 · C.R. Bard, Inc. · Apr 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
K060174 · Cook, Inc. · Feb 2006
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843 · Cook, Inc. · Aug 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · Cook, Inc. · Feb 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500 · Becton, Dickinson & CO · Jan 2004