510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K122152Substantially Equivalent

Oxti Inflation Device

Oxti Corporation, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122152 is the FDA 510(k) clearance record for OXTI INFLATION DEVICE, a class II device, cleared for Oxti Corporation on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list one 510(k) clearance for Oxti Corporation. As of , FDA records show no recalls naming K122152.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Oxti Corporation 7128 Staffordshire St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAV

Trailing 12 months
1 clearance under product code MAV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAV, 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 20261
October 20260