Cleared Traditional

K991390 - 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI

K991390 is an FDA 510(k) clearance for 1.5 M PROPANEDIOL FREEZING MEDIUM, manufactured by Sage Biopharma. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K991390 · Sage Biopharma · Obstetrics & Gynecology device
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Jan 2000
Decision
272d
Days
Class 2
Risk

K991390 is an FDA 510(k) clearance for the 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIU.... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Sage Biopharma (Irvine, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 272 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K991390

510(k) Number K991390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date January 18, 2000
Days to Decision 272 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
112d slower than avg
Panel avg: 160d · This submission: 272d
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 183
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K991390.
HUMAN SERUM ALBUMIN
K991392 · Advanced Reproductive Technologies · Feb 2000
QUINN'S SPERM WASHING MEDIUM
K991379 · Advanced Reproductive Technologies · Feb 2000
HYALURONIDASE, 80 U/ML
K991393 · Sage Biopharma · Feb 2000
PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
K991391 · Advanced Reproductive Technologies · Jan 2000
TYRODE'S SOLUTION-ACIDIFIED
K991339 · Irvine Scientific Sales Co., Inc. · Dec 1999
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
K991378 · Sage Biopharma · Sep 1999