Cleared Special

K020447 - MITYVAC MERLIN, MODEL 10027

K020447 is an FDA 510(k) clearance for MITYVAC MERLIN, manufactured by Prism Enterprises, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Special 510(k) pathway after a 60-day FDA review.

K020447 · Prism Enterprises, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
60d
Days
Class 2
Risk

K020447 is an FDA 510(k) clearance for the MITYVAC MERLIN, MODEL 10027. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Prism Enterprises, Inc. (Washington, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Prism Enterprises, Inc. devices

FDA 510(k) Submission Details - K020447

510(k) Number K020447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date April 12, 2002
Days to Decision 60 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 160d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

HDB Device Classification - Class 2, Special Controls

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HDB Extractor, Vacuum, Fetal

All 14
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