Cleared Traditional

K761070 - P.S.M. SURGICAL HOOD

K761070 is the FDA 510(k) clearance for P.S.M. SURGICAL HOOD by The Owenby Co.. It is a Class 2 General Hospital device (product code FXY) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K761070 · The Owenby Co. · General Hospital
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Dec 1976
Decision
44d
Days
Class 2
Risk

K761070 is an FDA 510(k) clearance for the P.S.M. SURGICAL HOOD. Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by The Owenby Co. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 44 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 Owenby Co. devices

Submission Details

510(k) Number K761070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1976
Decision Date December 30, 1976
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 8
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K761070.
DISPOSABLE BEARD COVER
K904276 · Anago, Inc. · Nov 1990
HOOD, CLARION SURGEONS
K770261 · Sherwood Medical Industries · Mar 1977
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · Sherwood Medical Industries · Feb 1977
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976
BARRIER FASHION BONNET
K760865 · Surgikos, Inc. · Nov 1976