510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891180Substantially Equivalent

Transesophageal Ultrasound Accessories Kit

Ingress Technologies, Inc., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891180 is the FDA 510(k) clearance record for TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT, a class II device, cleared for Ingress Technologies, Inc. on under FDA product code DXP (Transducer, Vessel Occlusion). FDA records list one 510(k) clearance for Ingress Technologies, Inc. As of , FDA records show no recalls naming K891180.

Clearance record

Decision date
Received
(101 days to decision)
Product code
DXP Transducer, Vessel Occlusion
Regulation
21 CFR 870.2890
Device class
Class II
Review panel
Cardiovascular
Applicant
Ingress Technologies, Inc. 3702 E. Roeser Rd., Suite 27, Phoenix AZ
Third party review
No

Clearances, product code DXP

Trailing 12 months

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

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