Cleared Traditional

K991395 - QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM

K991395 is an FDA 510(k) clearance for QUINN'S HTF MEDIUM, manufactured by Advanced Reproductive Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K991395 · Advanced Reproductive Technologies · Obstetrics & Gynecology device
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Feb 2000
Decision
300d
Days
Class 2
Risk

K991395 is an FDA 510(k) clearance for the QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIU.... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Advanced Reproductive Technologies (Irvine, US). The FDA issued a Cleared decision on February 15, 2000 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Advanced Reproductive Technologies devices

FDA 510(k) Submission Details - K991395

510(k) Number K991395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date February 15, 2000
Days to Decision 300 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 160d · This submission: 300d
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 187
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K991395.
OVOIL-150, MODEL 5002
K991351 · Vitrolife Sweden AB · Feb 2000
PH-100, MODEL 2104
K991346 · Vitrolife Sweden AB · Feb 2000
ASP-100, MODEL 2100
K991345 · Vitrolife Sweden AB · Feb 2000
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
K991396 · Sage Biopharma · Feb 2000
HUMAN SERUM ALBUMIN
K991392 · Advanced Reproductive Technologies · Feb 2000
QUINN'S SPERM WASHING MEDIUM
K991379 · Advanced Reproductive Technologies · Feb 2000