Cleared Traditional

K903533 - STERI-SHIELD

K903533 is an FDA 510(k) clearance for STERI-SHIELD, manufactured by Biomedical Devices, Inc.. The device is a Class 2 General Hospital device with product code FXY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K903533 · Biomedical Devices, Inc. · General Hospital
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Oct 1990
Decision
74d
Days
Class 2
Risk

K903533 is an FDA 510(k) clearance for the STERI-SHIELD. Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by Biomedical Devices, Inc. (Fullerton, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 74 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 Biomedical Devices, Inc. devices

FDA 510(k) Submission Details - K903533

510(k) Number K903533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1990
Decision Date October 19, 1990
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 8
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K903533.
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
K200493 · Stryker Corporation · Mar 2020
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
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · Sherwood Medical Industries · Feb 1977
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976