Cleared Traditional

K874318 - MAXIMUM CONTROL GOWN

K874318 is an FDA 510(k) clearance for MAXIMUM CONTROL GOWN, manufactured by Ulti-Med Intl., Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K874318 · Ulti-Med Intl., Inc. · General Hospital
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Dec 1987
Decision
43d
Days
Class 2
Risk

K874318 is an FDA 510(k) clearance for the MAXIMUM CONTROL GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Ulti-Med Intl., Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 2, 1987 after a review of 43 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 Ulti-Med Intl., Inc. devices

FDA 510(k) Submission Details - K874318

510(k) Number K874318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date December 02, 1987
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 46
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K874318.
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
OREX ISOLATION GOWN
K945223 · Thantex Specialties, Inc. · Apr 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
DISPOSABLE ISOLATION GOWN
K851823 · American Threshold Industries, Inc. · May 1985
CONTROL COVER GOWN
K840229 · Kimberly-Clark Corp. · Mar 1984
BARRIER PLUS SURGEON GOWNS
K801162 · American Hospital Supply Corp. · May 1980