Cleared Traditional

K020490 - PBS, PBSW WITH CATIONS AND PHENOL RED

K020490 is an FDA 510(k) clearance for PBS, manufactured by Conception Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K020490 · Conception Technologies · Obstetrics & Gynecology device
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Mar 2002
Decision
43d
Days
Class 2
Risk

K020490 is an FDA 510(k) clearance for the PBS, PBSW WITH CATIONS AND PHENOL RED. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Conception Technologies (Irvine, US). The FDA issued a Cleared decision on March 28, 2002 after a review of 43 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 Conception Technologies devices

FDA 510(k) Submission Details - K020490

510(k) Number K020490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2002
Decision Date March 28, 2002
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 160d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

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 197
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K020490.
ALLGRAD AND ALLGRAD100
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K013518 · Irvine Scientific Sales Co., Inc. · Jan 2002
OIL FOR EMBRYO CULTURE
K011938 · Irvine Scientific Sales Co., Inc. · Jul 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · Cook Urological, Inc. · May 2001