Cleared Traditional

K861117 - ANTHRON CATHETERS & SETS

K861117 is an FDA 510(k) clearance for ANTHRON CATHETERS & SETS, manufactured by Toray Industries (America), Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K861117 · Toray Industries (America), Inc. · General Hospital
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Jun 1986
Decision
85d
Days
Class 2
Risk

K861117 is an FDA 510(k) clearance for the ANTHRON CATHETERS & SETS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (New York, US). The FDA issued a Cleared decision on June 18, 1986 after a review of 85 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. 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.

View all Toray Industries (America), Inc. devices

FDA 510(k) Submission Details - K861117

510(k) Number K861117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1986
Decision Date June 18, 1986
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 403
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K861117.
SUPERCATH I.V. CATHETER
K864038 · Togo Medikit Co., Ltd. · Dec 1986
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.
K862130 · Menlo Care, Inc. · Aug 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479 · Burron Medical Products, Inc. · Jul 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510 · Warner-Lambert Co. · Jun 1986
STREAM LINE* I.V. CATHETER PLACEMENT UNIT
K860474 · Menlo Care, Inc. · May 1986
ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
K861015 · Acme United Corp. · Apr 1986