Cleared Traditional

K021992 - DHS DISPOSABLE HOOD SYSTEM

K021992 is an FDA 510(k) clearance for DHS DISPOSABLE HOOD SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K021992 · Biomet, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
210d
Days
Class 2
Risk

K021992 is an FDA 510(k) clearance for the DHS DISPOSABLE HOOD SYSTEM. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 14, 2003 after a review of 210 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 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. Standard predicate reliance. 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K021992

510(k) Number K021992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date January 14, 2003
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
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 212
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K021992.
STRYKER T4 HYTREL ZIPPER TOGA
K040764 · Stryker Corp. · Apr 2004
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
DEROYAL GOWNS, STERILE, NON-STERILE
K030364 · Deroyal Industries, Inc. · Apr 2003
BREATHABLE SURGICAL GOWN
K023167 · Allegiance Healthcare Corp. · Oct 2002
STRYKER T4 URETHANE HOOD
K022162 · Stryker Instruments · Aug 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · Allegiance Healthcare Corp. · Mar 2002