Cleared Traditional

K991345 - ASP-100, MODEL 2100

K991345 is an FDA 510(k) clearance for ASP-100, manufactured by Vitrolife Sweden AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K991345 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Feb 2000
Decision
305d
Days
Class 2
Risk

K991345 is an FDA 510(k) clearance for the ASP-100, MODEL 2100. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Gothenberg, SE). The FDA issued a Cleared decision on February 18, 2000 after a review of 305 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. Elevated predicate reliance profile. 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 Vitrolife Sweden AB devices

FDA 510(k) Submission Details - K991345

510(k) Number K991345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date February 18, 2000
Days to Decision 305 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
145d slower than avg
Panel avg: 160d · This submission: 305d
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 213
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K991345.
MEDI-CULT LIQUID PARAFFIN
K991330 · Medicult A/S · Feb 2000
OVOIL-150, MODEL 5002
K991351 · Vitrolife Sweden AB · Feb 2000
PH-100, MODEL 2104
K991346 · Vitrolife Sweden AB · Feb 2000
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
K991395 · Advanced Reproductive Technologies · 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