510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920091Substantially Equivalent

Iowa Oral Performance Isntrument

Breakthrough, Inc., Oakdale IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920091 is the FDA 510(k) clearance record for IOWA ORAL PERFORMANCE ISNTRUMENT, a class I device, cleared for Breakthrough, Inc. on under FDA product code IKE (Transducer, Miniature Pressure). FDA records list one 510(k) clearance for Breakthrough, Inc. As of , FDA records show no recalls naming K920091.

Clearance record

Decision date
Received
(133 days to decision)
Product code
IKE Transducer, Miniature Pressure
Regulation
21 CFR 890.1615
Device class
Class I
Review panel
Physical Medicine
Applicant
Breakthrough, Inc. 131 Technology Innovation Cent, Oakdale IA
510(k) summary
Statement
Third party review
No

Clearances, product code IKE

Trailing 12 months

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

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