Cleared Traditional

K991022 - SPERM WASHING MEDIA

K991022 is an FDA 510(k) clearance for SPERM WASHING MEDIA, manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K991022 · Intl., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
164d
Days
Class 2
Risk

K991022 is an FDA 510(k) clearance for the <GENX> SPERM WASHING MEDIA. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Madison, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 164 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 Intl., Inc. devices

FDA 510(k) Submission Details - K991022

510(k) Number K991022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date September 09, 1999
Days to Decision 164 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 160d · This submission: 164d
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 Consultant

Intl., Inc.
MICHAEL D CECCHI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

All 217
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K991022.
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
K991378 · Sage Biopharma · Sep 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
ENHANCE-S PLUS
K991322 · Conception Technology, Inc. · Jul 1999
FERTILIZATION MEDIA-HTF
K991173 · Intl., Inc. · Jul 1999
BOVINE SERUM ALBUMIN (BSA)
K991338 · Irvine Scientific Sales Co., Inc. · Jul 1999