Cleared Traditional

K052457 - PICSI SPERM SELECTION DEVICE

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

K052457 · Biocoat, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K052457

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
PCCP Authorized No
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.

MQK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 42
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K052457.
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009
SUNIVF DISHES
K080395 · Intl., Inc. · Aug 2008
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
K070047 · Nunc A/S · May 2007
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
K994361 · Genesis Industries, Inc. · Feb 2000
GENX CULTURE DISH
K993881 · Intl., Inc. · Feb 2000
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
K990941 · Humagen Fertility Diagnostics, Inc. · Jul 1999