Cleared Traditional

K102971 - FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

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

K102971 · Microtek Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K102971

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
Combination Product No
PCCP Authorized No
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.

FYA Device Classification - Class 2, Special Controls

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 224
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K102971.
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
K111535 · Exact Medical Manufacturing, Inc. · Aug 2011
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
K111067 · Kunshan Jiehong Nonwoven Product Co., Ltd. · Aug 2011
SURGICAL PROCEDURE PACKS
K110724 · Omnia Spa · Jun 2011
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · Kimberly-Clark Corp. · Dec 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · Kimberly-Clark Corp. · Mar 2010
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009