Cleared Traditional

K953120 - VITAL SIGNS HEPARIN VASCULAR ACCESS FLU...

K953120 is the FDA 510(k) clearance for VITAL SIGNS HEPARIN VASCULAR ACCESS FLU... by Vital Signs, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K953120 · Vital Signs, Inc. · General Hospital
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Dec 1995
Decision
161d
Days
Class 2
Risk

K953120 is an FDA 510(k) clearance for the VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 161 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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. Standard predicate reliance. 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K953120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1995
Decision Date December 13, 1995
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 273
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K953120.
ABRM CATHETER
K950118 · Cook, Inc. · Feb 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
K953335 · Micro Therapeutics, Inc. · Jan 1996
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
K952645 · Vital Signs, Inc. · Dec 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
K952058 · Trinity Laboratories, Inc. · Sep 1995
BIONECTOR
K941678 · Vygon Corp. · Jun 1995
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
K950284 · Sims Deltec, Inc. · May 1995