Cleared Traditional

K961402 - STS SHIELD WITH MASK

K961402 is an FDA 510(k) clearance for STS SHIELD WITH MASK, manufactured by Innovative Outsourcing Solutions. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K961402 · Innovative Outsourcing Solutions · General Hospital
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Jul 1996
Decision
92d
Days
Class 2
Risk

K961402 is an FDA 510(k) clearance for the STS SHIELD WITH MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Innovative Outsourcing Solutions (N. Chelmsford, US). The FDA issued a Cleared decision on July 12, 1996 after a review of 92 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 Innovative Outsourcing Solutions devices

FDA 510(k) Submission Details - K961402

510(k) Number K961402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date July 12, 1996
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 495
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K961402.
2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
K962286 · Berkley Medical Resources, Inc. · Oct 1996
BODILY FLUID DISPOSAL KIT
K961217 · Transidyne General Corp. · Jul 1996
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
K960048 · Safetec of America, Inc. · Jul 1996
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
FLUID RESISTANT MASK
K955556 · American Threshold Healthcare · Apr 1996
FLUID REISISTANT EYESHIELD MASK
K955557 · American Threshold Healthcare · Apr 1996