Cleared Traditional

K770261 - HOOD, CLARION SURGEONS

K770261 is an FDA 510(k) clearance for HOOD, manufactured by Sherwood Medical Industries. The device is a Class 2 General Hospital device with product code FXY cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K770261 · Sherwood Medical Industries · General Hospital
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Mar 1977
Decision
18d
Days
Class 2
Risk

K770261 is an FDA 510(k) clearance for the HOOD, CLARION SURGEONS. 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 March 1, 1977 after a review of 18 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.

FDA 510(k) Submission Details - K770261

510(k) Number K770261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1977
Decision Date March 01, 1977
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXY Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K770261.
STERI-SHIELD
K903533 · Biomedical Devices, Inc. · Oct 1990
STERI-SHIELD
K902677 · Biomedical Devices, Inc. · Aug 1990
CARETEX SURGEON'S HOODS
K880431 · James River Corp. · Feb 1988
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · Sherwood Medical Industries · Feb 1977
P.S.M. SURGICAL HOOD
K761070 · The Owenby Co. · Dec 1976
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976
K770261 · HOOD, CLARION SURGEONS
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