Cleared Traditional

K905460 - STERILE DISPOSABLE DRAPE/OPHTHALMIC SUR...

K905460 is the FDA 510(k) clearance for STERILE DISPOSABLE DRAPE/OPHTHALMIC SUR... by Angiosystems, Inc.. It is a Class 2 General Hospital device (product code HMT) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K905460 · Angiosystems, Inc. · General Hospital
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Feb 1991
Decision
63d
Days
Class 2
Risk

K905460 is an FDA 510(k) clearance for the STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY. Classified as Drape, Patient, Ophthalmic (product code HMT), Class II - Special Controls.

Submitted by Angiosystems, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 6, 1991 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Angiosystems, Inc. devices

Submission Details

510(k) Number K905460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date February 06, 1991
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HMT Drape, Patient, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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.