510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801239Substantially Equivalent

Sterile, Disp Dome, Individ. Pkg.

Pacific Domes, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801239 is the FDA 510(k) clearance record for STERILE, DISP DOME, INDIVID. PKG., a class II device, cleared for Pacific Domes, Inc. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list one 510(k) clearance for Pacific Domes, Inc. As of , FDA records show no recalls naming K801239.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Pacific Domes, Inc. 803 N. Front St. Suite 3, Mchenry IL
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