Cleared Traditional

K991378 - PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED

K991378 is an FDA 510(k) clearance for PHOSPHATE BUFFERED SALINE (PBS), 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 156-day FDA review.

K991378 · Sage Biopharma · Obstetrics & Gynecology device
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Sep 1999
Decision
156d
Days
Class 2
Risk

K991378 is an FDA 510(k) clearance for the PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGN.... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Sage Biopharma (Irvine, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 156 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.

View all Sage Biopharma devices

FDA 510(k) Submission Details - K991378

510(k) Number K991378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date September 24, 1999
Days to Decision 156 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
4d faster than avg
Panel avg: 160d · This submission: 156d
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 K991378.
1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
K991390 · Sage Biopharma · Jan 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
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
K991381 · Pacific Andrology, Inc. · Sep 1999
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI
K991419 · Irvine Scientific Sales Co., Inc. · Sep 1999
SPERM WASHING MEDIA
K991022 · Intl., Inc. · Sep 1999