510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861188Substantially Equivalent

Sperm Capacitation Medium

Irvine Scientific LLC, Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861188 is the FDA 510(k) clearance record for SPERM CAPACITATION MEDIUM, a class II device, cleared for Irvine Scientific on under FDA product code HDR (Cap, Cervical). FDA records list 16 510(k) clearances for Irvine Scientific, from to . As of , FDA records show no recalls naming K861188.

Clearance record

Decision date
Received
(281 days to decision)
Product code
HDR Cap, Cervical
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Irvine Scientific Charles H. Newman, Laguna Hills CA
Third party review
No

Clearances, product code HDR

Trailing 12 months

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

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