510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K042449Substantially Equivalent

Dolphin Inflation Device

Sedat S.A., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042449 is the FDA 510(k) clearance record for DOLPHIN INFLATION DEVICE, a class II device, cleared for Sedat S.A. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list one 510(k) clearance for Sedat S.A. As of , FDA records show 4 recalls naming K042449.

Clearance record

Decision date
Received
(221 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Sedat S.A. 45900 Parsippany Ct., Temecula CA
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