Cleared Traditional

K012123 - NIDOIL

K012123 is an FDA 510(k) clearance for NIDOIL, 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 28-day FDA review.

K012123 · Nidacon International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
28d
Days
Class 2
Risk

K012123 is an FDA 510(k) clearance for the NIDOIL. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Nidacon International AB (Deer Field, US). The FDA issued a Cleared decision on August 3, 2001 after a review of 28 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 Nidacon International AB devices

FDA 510(k) Submission Details - K012123

510(k) Number K012123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date August 03, 2001
Days to Decision 28 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
132d faster than avg
Panel avg: 160d · This submission: 28d
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 K012123.
SYDNEY IVF CULTURE OIL
K022002 · Cook Urological, Inc. · Aug 2002
EMBRYO BIOPSY MEDIUM
K021358 · Irvine Scientific Sales Co., Inc. · Jul 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · Irvine Scientific Sales Co., Inc. · Jan 2002
OIL FOR EMBRYO CULTURE
K011938 · Irvine Scientific Sales Co., Inc. · Jul 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · Cook Urological, Inc. · May 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · Intl., Inc. · May 2001