510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904601Substantially Equivalent

Advance Disposable Pressure Transducer

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

K904601 is the FDA 510(k) clearance record for ADVANCE DISPOSABLE PRESSURE TRANSDUCER, a class II device, cleared for Advance Medical Designs, Inc. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 32 510(k) clearances for Advance Medical Designs, Inc., from to . As of , FDA records show no recalls naming K904601.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Advance Medical Designs, Inc. 808 Pickens Industrial Dr., Marietta GA
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS 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 DRS, 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