Cleared Traditional

K092554 - BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES

K092554 is an FDA 510(k) clearance for BLASTOMERE BIOPSY PIPETTES, manufactured by Sunlight Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K092554 · Sunlight Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
253d
Days
Class 2
Risk

K092554 is an FDA 510(k) clearance for the BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Sunlight Medical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 253 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - 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.

FDA 510(k) Submission Details - K092554

510(k) Number K092554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date April 30, 2010
Days to Decision 253 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
92d slower than avg
Panel avg: 161d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
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 - MQH Microtools, Assisted Reproduction (pipettes)

All 25
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K092554.
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · Cook Incorporated · Dec 2015
BIOPSY PIPETTES
K133257 · Research Instruments , Ltd. · May 2014
INJECTION PIPETTE
K102480 · Jieying Laboratory, Inc. · Apr 2011
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
K072600 · Sunlight Medical, Inc. · May 2008
THE STRIPPER PGD
K041435 · Mid-Atlantic Diagnostics, Inc. · Sep 2004
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc. · Aug 2004
K092554 · BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
Download PDF FDA Summary Sunlight Medical, Inc.