Cleared Traditional

K110724 - SURGICAL PROCEDURE PACKS

K110724 is an FDA 510(k) clearance for SURGICAL PROCEDURE PACKS, manufactured by Omnia Spa. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K110724 · Omnia Spa · General Hospital
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Jun 2011
Decision
99d
Days
Class 2
Risk

K110724 is an FDA 510(k) clearance for the SURGICAL PROCEDURE PACKS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Omnia Spa (Carmel, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 99 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 Omnia Spa devices

FDA 510(k) Submission Details - K110724

510(k) Number K110724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date June 23, 2011
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 256
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K110724.
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
K120045 · Exact Medical Manufacturing, Inc. · Jun 2012
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
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
K101468 · 3M Company Corp · Apr 2011
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co. · Mar 2011
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · Microtek Medical, Inc. · Feb 2011