Cleared Traditional

K133257 - BIOPSY PIPETTES

K133257 is an FDA 510(k) clearance for BIOPSY PIPETTES, manufactured by Research Instruments , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K133257 · Research Instruments , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
205d
Days
Class 2
Risk

K133257 is an FDA 510(k) clearance for the BIOPSY PIPETTES. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Research Instruments , Ltd. (Cornwall, GB). The FDA issued a Cleared decision on May 16, 2014 after a review of 205 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 - K133257

510(k) Number K133257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2013
Decision Date May 16, 2014
Days to Decision 205 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 161d · This submission: 205d
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 K133257.
LifeGlobal Micro Tips
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Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
K151018 · Cook Incorporated · Jan 2016
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · Cook Incorporated · Dec 2015
INJECTION PIPETTE
K102480 · Jieying Laboratory, Inc. · Apr 2011
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
K092554 · Sunlight Medical, Inc. · Apr 2010
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
K072600 · Sunlight Medical, Inc. · May 2008