510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812102Substantially Equivalent

O.n.a.t.

Latex Medical Devices, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812102 is the FDA 510(k) clearance record for O.N.A.T., a class II device, cleared for Latex Medical Devices, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 3 510(k) clearances for Latex Medical Devices, Inc., from to . As of , FDA records show no recalls naming K812102.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Latex Medical Devices, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KNT

Trailing 12 months
3 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260