Cleared Traditional

K970835 - FACE MASK, SURGICAL MASK, NON-STERILE

K970835 is an FDA 510(k) clearance for FACE MASK, manufactured by Tucker & Associates. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K970835 · Tucker & Associates · General Hospital
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Sep 1997
Decision
196d
Days
Class 2
Risk

K970835 is an FDA 510(k) clearance for the FACE MASK, SURGICAL MASK, NON-STERILE. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tucker & Associates (Green Valley, US). The FDA issued a Cleared decision on September 3, 1997 after a review of 196 days - an extended review 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: 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 Tucker & Associates devices

FDA 510(k) Submission Details - K970835

510(k) Number K970835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1997
Decision Date September 03, 1997
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 129d · This submission: 196d
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 464
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K970835.
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