Cleared Traditional

K963568 - MASK SURGICAL

K963568 is an FDA 510(k) clearance for MASK SURGICAL, manufactured by The Innovative Approach, Corp.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K963568 · The Innovative Approach, Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
173d
Days
Class 2
Risk

K963568 is an FDA 510(k) clearance for the MASK SURGICAL. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by The Innovative Approach, Corp. (Hato Rey, US). The FDA issued a Cleared decision on February 25, 1997 after a review of 173 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 The Innovative Approach, Corp. devices

FDA 510(k) Submission Details - K963568

510(k) Number K963568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date February 25, 1997
Days to Decision 173 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 129d · This submission: 173d
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 500
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K963568.
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