510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022643Substantially Equivalent

Blastomere Biopsy Pipette, Models H-55530 and H-55540

Swemed Lab International AB, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022643 is the FDA 510(k) clearance record for BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540, a class II device, cleared for Swemed Lab International AB on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 4 510(k) clearances for Swemed Lab International AB, from to . As of , FDA records show no recalls naming K022643.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MQH Microtools, Assisted Reproduction (Pipettes)
Regulation
21 CFR 884.6130
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Swemed Lab International AB 555 13th St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQH

Trailing 12 months

FDA records hold no clearances under product code MQH in the trailing twelve months.

FDA records show no clearances under product code MQH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260