510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K013401Substantially Equivalent

K-Systems Culture Bag Sealer and Culture Bags Type Cbs-1 and Cb-01

K-Systems, Kivex Biotec, Ltd., Birkerod, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013401 is the FDA 510(k) clearance record for K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01, a class II device, cleared for K-Systems, Kivex Biotec , Ltd. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list one 510(k) clearance for K-Systems, Kivex Biotec , Ltd. As of , FDA records show no recalls naming K013401.

Clearance record

Decision date
Received
(60 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
K-Systems, Kivex Biotec , Ltd. Klintehoj Vaenge 21, Birkerod, DK
510(k) summary
Statement
Third party review
No

Clearances, product code MQG

Trailing 12 months
2 clearances under product code MQG in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260