Cleared Traditional

K013401 - K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

K013401 is an FDA 510(k) clearance for K-SYSTEMS CULTURE BAG SEALER AND CULTUR..., manufactured by K-Systems, Kivex Biotec , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K013401 · K-Systems, Kivex Biotec , Ltd. · Obstetrics & Gynecology device
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Dec 2001
Decision
60d
Days
Class 2
Risk

K013401 is an FDA 510(k) clearance for the K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by K-Systems, Kivex Biotec , Ltd. (Birkerod, DK). The FDA issued a Cleared decision on December 14, 2001 after a review of 60 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.

View all K-Systems, Kivex Biotec , Ltd. devices

FDA 510(k) Submission Details - K013401

510(k) Number K013401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 14, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 160d · This submission: 60d
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 29
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K013401.
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K111715 · Unisense Fertilitech A/S · Aug 2011
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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
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K000394 · Rocket Medical Plc · Feb 2000