Cleared Traditional

K000989 - SPERM WASH MEDIUM, CAT# 2003/2005

K000989 is an FDA 510(k) clearance for SPERM WASH MEDIUM, manufactured by Invitrocare, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K000989 · Invitrocare, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
72d
Days
Class 2
Risk

K000989 is an FDA 510(k) clearance for the SPERM WASH MEDIUM, CAT# 2003/2005. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Invitrocare, Inc. (San Diego, US). The FDA issued a Cleared decision on June 8, 2000 after a review of 72 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 Invitrocare, Inc. devices

FDA 510(k) Submission Details - K000989

510(k) Number K000989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2000
Decision Date June 08, 2000
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
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 198
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K000989.
MEDI-CULT UNIVERSAL IVF-MEDIUM
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MEDI-CULT M3 MEDIUM
K991331 · Medicult A/S · Jun 2000
MEDI-CULT HYALURONIDASE
K991334 · Medicult A/S · Jun 2000
Q-HTF, CAT# 2001
K993484 · Invitrocare, Inc. · May 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348 · Vitrolife Sweden AB · May 2000
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)
K991471 · Medicult A/S · May 2000