Cleared Traditional

K962802 - SAFE MATE I.V. FLUID DELIVERY SETS

K962802 is an FDA 510(k) clearance for SAFE MATE I.V. FLUID DELIVERY SETS, manufactured by Biological & Environmental Control Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K962802 · Biological & Environmental Control Laboratories · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
41d
Days
Class 2
Risk

K962802 is an FDA 510(k) clearance for the SAFE MATE I.V. FLUID DELIVERY SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Biological & Environmental Control Laboratories (Toledo, US). The FDA issued a Cleared decision on August 28, 1996 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K962802

510(k) Number K962802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date August 28, 1996
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 968
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K962802.
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
K961928 · Biomedix, Inc. · Sep 1996
VENIPUNCTURE KIT
K963070 · Miller Products and Services · Sep 1996
SAFE MATE I.V. EXTENSION SETS
K962801 · Biological & Environmental Control Laboratories · Aug 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · Merit Medical Systems, Inc. · Aug 1996
I.V. ADMINISTRATION SETS
K955821 · Medical Associates Network, Inc. · Jul 1996
STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
K960391 · Strato/Infusaid, Inc. · Jul 1996
K962802 · SAFE MATE I.V. FLUID DELIVERY SETS
Download PDF FDA Summary Biological & Environm…