Cleared Traditional

K021358 - EMBRYO BIOPSY MEDIUM

K021358 is an FDA 510(k) clearance for EMBRYO BIOPSY MEDIUM, manufactured by Irvine Scientific Sales Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K021358 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
67d
Days
Class 2
Risk

K021358 is an FDA 510(k) clearance for the EMBRYO BIOPSY MEDIUM. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 5, 2002 after a review of 67 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 Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K021358

510(k) Number K021358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2002
Decision Date July 05, 2002
Days to Decision 67 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
93d faster than avg
Panel avg: 160d · This submission: 67d
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 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K021358.
LITE MINERAL OIL
K022332 · Intl., Inc. · Aug 2002
ALLGRAD AND ALLGRAD100
K022335 · Intl., Inc. · Aug 2002
SYDNEY IVF CULTURE OIL
K022002 · Cook Urological, Inc. · Aug 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
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