Cleared Traditional

K871558 - DENTAL FACE MASKS, POLYESTER

K871558 is an FDA 510(k) clearance for DENTAL FACE MASKS, manufactured by Carl Parker Associates, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K871558 · Carl Parker Associates, Inc. · General Hospital
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Jul 1987
Decision
91d
Days
Class 2
Risk

K871558 is an FDA 510(k) clearance for the DENTAL FACE MASKS, POLYESTER. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Carl Parker Associates, Inc. (Hauppauge, US). The FDA issued a Cleared decision on July 22, 1987 after a review of 91 days - within the typical 510(k) review window.

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: 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 Carl Parker Associates, Inc. devices

FDA 510(k) Submission Details - K871558

510(k) Number K871558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1987
Decision Date July 22, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 465
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K871558.
INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
K874296 · Ulti-Med Intl., Inc. · 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
TECNOL CLASSIC CONE MASK
K870056 · Tecnol New Jersey Wound Care, Inc. · Feb 1987
OP-FACE MASK(MASQUE DE CHIRUGIE)
K851556 · Roseburg SA · Apr 1985
PERITONEAL DIALYSIS COIL CATHETER
K850247 · Sil-Med Corp. · Feb 1985