510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K112644Substantially Equivalent

Seaforia Sperm Separation Assistance System

Lotus Bio, Ltd., Pawtucket RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112644 is the FDA 510(k) clearance record for SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM, a class II device, cleared for Lotus Bio, Ltd. on under FDA product code MQK (Labware, Assisted Reproduction). FDA records list one 510(k) clearance for Lotus Bio, Ltd. As of , FDA records show no recalls naming K112644.

Clearance record

Decision date
Received
(464 days to decision)
Product code
MQK Labware, Assisted Reproduction
Regulation
21 CFR 884.6160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lotus Bio, Ltd. 461 Main St., Pawtucket RI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQK

Trailing 12 months
1 clearance under product code MQK in the twelve months to October 2026, October 2026 the highest month at 1.
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 20261