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
K780035Substantially Equivalent

Minivisor

Metrix Teknika, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780035 is the FDA 510(k) clearance record for MINIVISOR, a class II device, cleared for Metrix Teknika, Inc. on under FDA product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic). FDA records list 4 510(k) clearances for Metrix Teknika, Inc., from to . As of , FDA records show no recalls naming K780035.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HEL Monitor, Heart Rate, Fetal, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Metrix Teknika, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HEL

Trailing 12 months

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

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