Cleared Traditional

K023465 - KENDRO HERACELL 240 INCUBATOR

K023465 is an FDA 510(k) clearance for KENDRO HERACELL 240 INCUBATOR, manufactured by Kendro Laboratory Products, L.P.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K023465 · Kendro Laboratory Products, L.P. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
146d
Days
Class 2
Risk

K023465 is an FDA 510(k) clearance for the KENDRO HERACELL 240 INCUBATOR. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Kendro Laboratory Products, L.P. (Huntington, US). The FDA issued a Cleared decision on March 10, 2003 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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 Kendro Laboratory Products, L.P. devices

FDA 510(k) Submission Details - K023465

510(k) Number K023465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date March 10, 2003
Days to Decision 146 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
14d faster than avg
Panel avg: 160d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 26
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K023465.
PLANER BT37 INCUBATOR
K121566 · Planer Plc · Nov 2012
EMBRYO VIEWER SOFTWARE
K113075 · Unisense Fertilitech A/S · Dec 2011
EMBRYOSCOPE
K111715 · Unisense Fertilitech A/S · Aug 2011
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000