Cleared Traditional

K983580 - BLASTOCYST MEDIUM

K983580 is an FDA 510(k) clearance for BLASTOCYST 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 128-day FDA review.

K983580 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
128d
Days
Class 2
Risk

K983580 is an FDA 510(k) clearance for the BLASTOCYST 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 February 18, 1999 after a review of 128 days - within the typical 510(k) review window.

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: 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.

View all Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K983580

510(k) Number K983580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date February 18, 1999
Days to Decision 128 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
32d faster than avg
Panel avg: 160d · This submission: 128d
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 K983580.
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)
K991421 · Irvine Scientific Sales Co., Inc. · Jul 1999
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
K983588 · Irvine Scientific Sales Co., Inc. · Apr 1999
SYNTHETIC SERUM SUBSTITUTE (SSS)
K983579 · Irvine Scientific Sales Co., Inc. · Apr 1999
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI
K983586 · Irvine Scientific Sales Co., Inc. · Feb 1999
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM
K983589 · Irvine Scientific Sales Co., Inc. · Feb 1999
HUMAN SERUM ALBUMIN (HSA)
K983584 · Irvine Scientific Sales Co., Inc. · Feb 1999