Cleared Traditional

K102971 - FREEDOMAIRE III SURGICAL HELMET SYSTEM ...

K102971 is the FDA 510(k) clearance for FREEDOMAIRE III SURGICAL HELMET SYSTEM ... by Microtek Medical, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K102971 · Microtek Medical, Inc. · General Hospital
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Feb 2011
Decision
140d
Days
Class 2
Risk

K102971 is an FDA 510(k) clearance for the FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 140 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 Microtek Medical, Inc. devices

Submission Details

510(k) Number K102971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2010
Decision Date February 23, 2011
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 148
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