Cleared Traditional

K870056 - TECNOL CLASSIC CONE MASK

K870056 is an FDA 510(k) clearance for TECNOL CLASSIC CONE MASK, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K870056 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Feb 1987
Decision
30d
Days
Class 2
Risk

K870056 is an FDA 510(k) clearance for the TECNOL CLASSIC CONE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K870056

510(k) Number K870056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1987
Decision Date February 06, 1987
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K870056.
SAFETY SHIELD KIT
K873731 · Ballard Medical Products · Jan 1988
TECNOL FLUID SHIELD SURGICAL MASK
K874608 · Tecnol New Jersey Wound Care, Inc. · Dec 1987
TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE
K873785 · Tecnol New Jersey Wound Care, Inc. · Nov 1987
OP-FACE MASK(MASQUE DE CHIRUGIE)
K851556 · Roseburg SA · Apr 1985
PERITONEAL DIALYSIS COIL CATHETER
K850247 · Sil-Med Corp. · Feb 1985
HIGH FILTRATION ISO-MASK
K831148 · Tecnol New Jersey Wound Care, Inc. · Jul 1984