510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090832Substantially Equivalent

Rapid-I

Vitrolife Sweden AB, Se-400 92 Goteborg, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090832 is the FDA 510(k) clearance record for RAPID-I, a class II device, cleared for Vitrolife Sweden AB on under FDA product code MQK (Labware, Assisted Reproduction). FDA records list 38 510(k) clearances for Vitrolife Sweden AB, from to . As of , FDA records show no recalls naming K090832.

Clearance record

Decision date
Received
(272 days to decision)
Product code
MQK Labware, Assisted Reproduction
Regulation
21 CFR 884.6160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Vitrolife Sweden AB Box 9080, Se-400 92 Goteborg, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQK

Trailing 12 months

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

FDA records show no clearances under product code MQK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQK, 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