Cleared Traditional

K861015 - ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS

K861015 is an FDA 510(k) clearance for ONE TIME HYPERAL & CATHETER DRESSING CH..., manufactured by Acme United Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K861015 · Acme United Corp. · General Hospital
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Apr 1986
Decision
35d
Days
Class 2
Risk

K861015 is an FDA 510(k) clearance for the ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Acme United Corp. (Fairfield, US). The FDA issued a Cleared decision on April 22, 1986 after a review of 35 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 Acme United Corp. devices

FDA 510(k) Submission Details - K861015

510(k) Number K861015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 22, 1986
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 413
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K861015.
ANTHRON CATHETERS & SETS
K861117 · Toray Industries (America), Inc. · Jun 1986
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STREAM LINE* I.V. CATHETER PLACEMENT UNIT
K860474 · Menlo Care, Inc. · May 1986
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
VIAPIC CENTRAL LINE CATHETER
K860290 · Parke-Davis Co. · Mar 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566 · Terumo Medical Corp. · Jan 1986