Cleared Traditional

K172197 - SAGE 1-Step GM-CSF with HSA

K172197 is the FDA 510(k) clearance for SAGE 1-Step GM-CSF with HSA by Origio A/S. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K172197 · Origio A/S · Obstetrics & Gynecology device
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Oct 2017
Decision
84d
Days
Class 2
Risk

K172197 is an FDA 510(k) clearance for the SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on October 13, 2017 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Origio A/S devices

Submission Details

510(k) Number K172197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date October 13, 2017
Days to Decision 84 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
76d faster than avg
Panel avg: 160d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K172197.
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