Cleared Traditional

K801025 - ODOR MASKING AGENT FOR CONTENTS OF ALL

K801025 is an FDA 510(k) clearance for ODOR MASKING AGENT FOR CONTENTS OF ALL, manufactured by The Buckeye Cellulose Corp.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K801025 · The Buckeye Cellulose Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
32d
Days
Class 2
Risk

K801025 is an FDA 510(k) clearance for the ODOR MASKING AGENT FOR CONTENTS OF ALL. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by The Buckeye Cellulose Corp. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980 after a review of 32 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 The Buckeye Cellulose Corp. devices

FDA 510(k) Submission Details - K801025

510(k) Number K801025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1980
Decision Date May 30, 1980
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 227
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K801025.
BONDARY SINGLE-USE OR GOWN
K813390 · The Buckeye Cellulose Corp. · Jan 1982
BOUNDARY REINFORCED OR GOWN
K811958 · The Buckeye Cellulose Corp. · Jul 1981
IRRADIATED BOUNDARY DEVICES
K803158 · The Buckeye Cellulose Corp. · Jan 1981
WHITE KNIGHT DISP. STERILE BACK GOWN
K800927 · G.D. Searle and Co. · May 1980
WHITE KNIGHT SURGICAL PACK
K800929 · G.D. Searle and Co. · May 1980
STERILIZATION PROCESS /USE GOWNS
K792622 · Procter & Gamble Mfg. Co. · Jan 1980