Cleared Traditional

K170681 - Continuous Single Culture -NX (CSCM-NX)

K170681 is an FDA 510(k) clearance for Continuous Single Culture -NX (CSCM-NX), manufactured by Irvine Scientific Sales Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K170681 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
94d
Days
Class 2
Risk

K170681 is an FDA 510(k) clearance for the Continuous Single Culture -NX (CSCM-NX). Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 8, 2017 after a review of 94 days - within the typical 510(k) review window.

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 Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K170681

510(k) Number K170681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date June 08, 2017
Days to Decision 94 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
67d faster than avg
Panel avg: 161d · This submission: 94d
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 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K170681.
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
K172197 · Origio A/S · Oct 2017
Gems Oocyte Retrieval Buffer ORB-20, ORB-50
K170498 · Genea Biomedx Pty, Ltd. · Sep 2017
Arctic Sperm Cryopreservation Medium
K171224 · Irvine Scientific Sales Co., Inc. · Aug 2017
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602 · Irvine Scientific Sales Co., Inc. · Jun 2017
Gems Vitrification Set, Gems Warming Set
K162409 · Genea Biomedx Pty, Ltd. · May 2017
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
K161261 · Genea Biomedx Pty, Ltd. · May 2017