Cleared Traditional

K080172 - BLASTASSIST WITHOUT PHENOL RED

K080172 is an FDA 510(k) clearance for BLASTASSIST WITHOUT PHENOL RED, manufactured by Medicult A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K080172 · Medicult A/S · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
329d
Days
Class 2
Risk

K080172 is an FDA 510(k) clearance for the BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, .... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Medicult A/S (San Diego, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 329 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 Medicult A/S devices

FDA 510(k) Submission Details - K080172

510(k) Number K080172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2008
Decision Date December 18, 2008
Days to Decision 329 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 160d · This submission: 329d
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 167
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