Cleared Traditional

K002805 - KENDRO HERACELL CO2 INCUBATOR

K002805 is an FDA 510(k) clearance for KENDRO HERACELL CO2 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 62-day FDA review.

K002805 · Kendro Laboratory Products, L.P. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
62d
Days
Class 2
Risk

K002805 is an FDA 510(k) clearance for the KENDRO HERACELL CO2 INCUBATOR. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Kendro Laboratory Products, L.P. (Great Neck, US). The FDA issued a Cleared decision on November 9, 2000 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002805

510(k) Number K002805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2000
Decision Date November 09, 2000
Days to Decision 62 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
99d faster than avg
Panel avg: 161d · This submission: 62d
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 46
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K002805.
MINITUB MULTI-PURPOSE CASSETTES
K002961 · Zander Medical Supplies, Inc. · Nov 2000
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
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CBS STRAW
K002595 · Cryo Bio System · Nov 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
K001524 · Thermoquest Corp. · Jul 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K000394 · Rocket Medical Plc · Feb 2000
K002805 · KENDRO HERACELL CO2 INCUBATOR
Download PDF FDA Summary Kendro Laboratory Pro…