Cleared Abbreviated

K080707 - SRI PLR GOWN

K080707 is an FDA 510(k) clearance for SRI PLR GOWN, manufactured by Sri/Surgical Express. The device is a Class 2 General Hospital device with product code FYA cleared through the Abbreviated 510(k) pathway after a 246-day FDA review.

K080707 · Sri/Surgical Express · General Hospital
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Nov 2008
Decision
246d
Days
Class 2
Risk

K080707 is an FDA 510(k) clearance for the SRI PLR GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Sri/Surgical Express (Austin, US). The FDA issued a Cleared decision on November 13, 2008 after a review of 246 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080707

510(k) Number K080707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2008
Decision Date November 13, 2008
Days to Decision 246 days
Submission Type Abbreviated
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
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Standards-based clearance path.

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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K080707.
SRI LEVEL II SURGICAL GOWN
K090383 · Sri Surgical · May 2009
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
K091097 · Promedical Products Co., Ltd. · May 2009
SKLAR SURGICAL GOWN
K082479 · Sklar Corp. · Apr 2009
SRI LP GOWN
K080723 · Sri/Surgical Express, Inc. · Nov 2008
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
K080795 · Kimberly-Clark Corp. · Sep 2008
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
K080627 · Promedical Products Co., Ltd. · Apr 2008
K080707 · SRI PLR GOWN
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