510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182905Substantially Equivalent

UniPulse

Seaward Group, Peterlee, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182905 is the FDA 510(k) clearance record for UniPulse, a class II device, cleared for Seaward Group on under FDA product code DRL (Tester, Defibrillator). FDA records list one 510(k) clearance for Seaward Group. As of , FDA records show no recalls naming K182905.

Clearance record

Decision date
Received
(59 days to decision)
Product code
DRL Tester, Defibrillator
Regulation
21 CFR 870.5325
Device class
Class II
Review panel
Cardiovascular
Applicant
Seaward Group 15-18 Bracken Hill, Peterlee, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRL

Trailing 12 months

FDA records hold no clearances under product code DRL in the trailing twelve months.

FDA records show no clearances under product code DRL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRL, 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 20260
October 20260