Cleared Traditional

K934664 - HYDRAGOWN (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934664 · Mallinckrodt Group, Inc. · General Hospital
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May 1994
Decision
238d
Days
Class 2
Risk

K934664 is an FDA 510(k) clearance for the HYDRAGOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 24, 1994 after a review of 238 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mallinckrodt Group, Inc. devices

Submission Details

510(k) Number K934664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1993
Decision Date May 24, 1994
Days to Decision 238 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 128d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 292
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