Cleared Traditional

K850177 - MATRIX DRI-IDEA (PLASTIC DISPOS. SURGIC...

K850177 is the FDA 510(k) clearance for MATRIX DRI-IDEA (PLASTIC DISPOS. SURGIC... by Matrix Medica, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K850177 · Matrix Medica, Inc. · General Hospital
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Feb 1985
Decision
35d
Days
Class 2
Risk

K850177 is an FDA 510(k) clearance for the MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Matrix Medica, Inc. (Minden, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Matrix Medica, Inc. devices

Submission Details

510(k) Number K850177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1985
Decision Date February 21, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
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 129
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K850177.
KIMBERLY-CLARK PROTECTIVE SLEEVE
K880386 · Kimberly-Clark Corp. · Jun 1988
THEATRE GOWNS
K872758 · Smith & Nephew, Inc. · Jul 1987
SPUNGUARD PLUS SURGICAL GOWN
K861600 · Kimberly-Clark Corp. · May 1986
BOUNDARY SINGLE-USE OR GOWN
K842958 · Procter & Gamble Mfg. Co. · Aug 1984
BOUNDARY SINGLE-USE GOWNS
K834332 · Procter & Gamble Mfg. Co. · May 1984
STERILIZATION PROCESS /USE GOWNS
K792622 · Procter & Gamble Mfg. Co. · Jan 1980