510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002451Substantially Equivalent

Modification to: Pronto Dry

Medical Instruments S.p.A., Solothurn, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002451 is the FDA 510(k) clearance record for MODIFICATION TO: PRONTO DRY, a class I device, cleared for Medical Instruments Corporation, AG on under FDA product code LYR (Helicobacter Pylori). FDA records list one 510(k) clearance for Medical Instruments Corporation, AG. As of , FDA records show no recalls naming K002451.

Clearance record

Decision date
Received
(51 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Medical Instruments Corporation, AG Pob 706 Ch-4502, Solothurn, CH
510(k) summary
Statement
Third party review
No

Clearances, product code LYR

Trailing 12 months

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

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