510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K173075Substantially Equivalent

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

DxNow Inc., Gaithersburg MD / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173075 is the FDA 510(k) clearance record for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml), a class II device, cleared for Dxnow, Inc. on under FDA product code MQK (Labware, Assisted Reproduction). FDA records list one 510(k) clearance for Dxnow, Inc. As of , FDA records show no recalls naming K173075.

Clearance record

Decision date
Received
(160 days to decision)
Product code
MQK Labware, Assisted Reproduction
Regulation
21 CFR 884.6160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Dxnow, Inc. 401 Professional Dr., Suite 130, Gaithersburg MD
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