Cleared Traditional

K002383 - COOK IVF SPERM BUFFER

K002383 is the FDA 510(k) clearance for COOK IVF SPERM BUFFER by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K002383 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
40d
Days
Class 2
Risk

K002383 is an FDA 510(k) clearance for the COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on September 13, 2000 after a review of 40 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Ob/Gyn devices

Submission Details

510(k) Number K002383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date September 13, 2000
Days to Decision 40 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
120d faster than avg
Panel avg: 160d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K002383.
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
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K003448 · Irvine Scientific Sales Co., Inc. · Dec 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · Cook Ob/Gyn · Sep 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348 · Vitrolife Sweden AB · May 2000
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
K000309 · Irvine Scientific Sales Co., Inc. · Mar 2000
OVOIL-150, MODEL 5002
K991351 · Vitrolife Sweden AB · Feb 2000