Cleared Special

K030116 - ENHANCE-S PLUS H

K030116 is the FDA 510(k) clearance for ENHANCE-S PLUS H by Conception Technology, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Special 510(k) pathway after a 30-day FDA review.

K030116 · Conception Technology, Inc. · Obstetrics & Gynecology device
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Feb 2003
Decision
30d
Days
Class 2
Risk

K030116 is an FDA 510(k) clearance for the ENHANCE-S PLUS H. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Conception Technology, Inc. (Irvine, US). The FDA issued a Cleared decision on February 12, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Conception Technology, Inc. devices

Submission Details

510(k) Number K030116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2003
Decision Date February 12, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 122
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