Cleared Traditional

K092107 - VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010

K092107 is an FDA 510(k) clearance for VITRIBLAST, manufactured by Nidacon International AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K092107 · Nidacon International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
336d
Days
Class 2
Risk

K092107 is an FDA 510(k) clearance for the VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Nidacon International AB (Deerfield, US). The FDA issued a Cleared decision on June 15, 2010 after a review of 336 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 Nidacon International AB devices

FDA 510(k) Submission Details - K092107

510(k) Number K092107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date June 15, 2010
Days to Decision 336 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 160d · This submission: 336d
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 168
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K092107.
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