Cleared Traditional

K941845 - BUSE STAFF PROTECTION GOWNS AND KITS

K941845 is an FDA 510(k) clearance for BUSE STAFF PROTECTION GOWNS AND KITS, manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K941845 · Busse Hospital Disposables, Inc. · General Hospital
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May 1995
Decision
391d
Days
Class 2
Risk

K941845 is an FDA 510(k) clearance for the BUSE STAFF PROTECTION GOWNS AND KITS. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Busse Hospital Disposables, Inc. devices

FDA 510(k) Submission Details - K941845

510(k) Number K941845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date May 10, 1995
Days to Decision 391 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
262d slower than avg
Panel avg: 129d · This submission: 391d
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 47
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K941845.
KOOL GARD SINGLES GOWN
K952114 · American Threshold Industries, Inc. · Sep 1995
BARRIER GOWN, KOOL-GARD BACKLESS GOWN
K952115 · American Threshold Industries, Inc. · Sep 1995
COVER GOWN
K952116 · American Threshold Industries, Inc. · Sep 1995
OREX ISOLATION GOWN
K945223 · Thantex Specialties, Inc. · Apr 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
MAXIMUM CONTROL GOWN
K874318 · Ulti-Med Intl., Inc. · Dec 1987