Cleared Traditional

K991381 - PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA

K991381 is an FDA 510(k) clearance for PURECEPTION LOWER PHASE, manufactured by Pacific Andrology, Inc.. 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.

K991381 · Pacific Andrology, Inc. · Obstetrics & Gynecology device
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Sep 1999
Decision
156d
Days
Class 2
Risk

K991381 is an FDA 510(k) clearance for the PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFF.... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Pacific Andrology, Inc. (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 Pacific Andrology, Inc. devices

FDA 510(k) Submission Details - K991381

510(k) Number K991381 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 K991381.
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
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
ENHANCE-S PLUS
K991322 · Conception Technology, Inc. · Jul 1999