Cleared Traditional

K770257 - HOOD & BEARD COVER

K770257 is the FDA 510(k) clearance for HOOD & BEARD COVER by Sherwood Medical Industries. It is a Class 2 General Hospital device (product code FXY) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K770257 · Sherwood Medical Industries · General Hospital
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Feb 1977
Decision
14d
Days
Class 2
Risk

K770257 is an FDA 510(k) clearance for the HOOD & BEARD COVER, CLARION SURGEON'S. Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on February 25, 1977 after a review of 14 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 Sherwood Medical Industries devices

Submission Details

510(k) Number K770257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1977
Decision Date February 25, 1977
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXY Hood, 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 - FXY Hood, Surgical

All 7
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K770257.
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588 · Stryker Corporation · Jun 2014
DISPOSABLE BEARD COVER
K904276 · Anago, Inc. · Nov 1990
HOOD, CLARION SURGEONS
K770261 · Sherwood Medical Industries · Mar 1977
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976
BARRIER FASHION BONNET
K760865 · Surgikos, Inc. · Nov 1976