Cleared Traditional

K052457 - PICSI SPERM SELECTION DEVICE

K052457 is the FDA 510(k) clearance for PICSI SPERM SELECTION DEVICE by Biocoat, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQK) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K052457 · Biocoat, Inc. · Obstetrics & Gynecology device
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Apr 2006
Decision
218d
Days
Class 2
Risk

K052457 is an FDA 510(k) clearance for the PICSI SPERM SELECTION DEVICE. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Biocoat, Inc. (Horsham, US). The FDA issued a Cleared decision on April 13, 2006 after a review of 218 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocoat, Inc. devices

Submission Details

510(k) Number K052457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date April 13, 2006
Days to Decision 218 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 160d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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.