Cleared Traditional

K873705 - CARERITE FACE MASK

K873705 is an FDA 510(k) clearance for CARERITE FACE MASK, manufactured by Cost Rite Health Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K873705 · Cost Rite Health Products, Inc. · General Hospital
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Oct 1987
Decision
21d
Days
Class 2
Risk

K873705 is an FDA 510(k) clearance for the CARERITE FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Cost Rite Health Products, Inc. (Chatsworth, US). The FDA issued a Cleared decision on October 5, 1987 after a review of 21 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 Cost Rite Health Products, Inc. devices

FDA 510(k) Submission Details - K873705

510(k) Number K873705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1987
Decision Date October 05, 1987
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 453
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K873705.
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