510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852978Substantially Equivalent

Comfort - Cuf

Dynasty Instruments, Ltd., Indialantic FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852978 is the FDA 510(k) clearance record for COMFORT - CUF, a class II device, cleared for Dynasty Instruments, Ltd. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list one 510(k) clearance for Dynasty Instruments, Ltd. As of , FDA records show no recalls naming K852978.

Clearance record

Decision date
Received
(183 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Dynasty Instruments, Ltd. 724 Puesta Del Sol, Indialantic FL
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261