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
K853188Substantially Equivalent

Transfer Device

Advance Medical Designs Inc, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853188 is the FDA 510(k) clearance record for TRANSFER DEVICE, a class II device, cleared for Advance Medical Designs, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 32 510(k) clearances for Advance Medical Designs, Inc., from to . As of , FDA records show no recalls naming K853188.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Advance Medical Designs, Inc. 1400 Marietta Pkwy., Su 105, Marietta GA
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260