Cleared Traditional

K854290 - MEDSURG AMNIOCENTESIS TRAY (FDA 510(k) Clearance)

K854290 · Medsurg Industries, Inc. · Obstetrics & Gynecology device
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Jan 1986
Decision
91d
Days
-
Risk

K854290 is an FDA 510(k) clearance for the MEDSURG AMNIOCENTESIS TRAY.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel. 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K854290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 25, 1985
Decision Date January 24, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 160d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -