510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864229Substantially Equivalent

Sta-Set Model 250 i.v. Flow Regulator

Sta-Set Corp., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864229 is the FDA 510(k) clearance record for STA-SET MODEL 250 I.V. FLOW REGULATOR, a class II device, cleared for Sta-Set Corp. on under FDA product code LDR (Controller, Infusion, Intravascular, Electronic). FDA records list one 510(k) clearance for Sta-Set Corp. As of , FDA records show no recalls naming K864229.

Clearance record

Decision date
Received
(49 days to decision)
Product code
LDR Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Sta-Set Corp. 3715 Vineyard Dr., Houston TX
Third party review
No

Clearances, product code LDR

Trailing 12 months

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

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