510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802591Substantially Equivalent

Model 5460 + 5480 Pop-Off Valves

G. Dundas Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802591 is the FDA 510(k) clearance record for MODEL 5460 + 5480 POP-OFF VALVES, a class II device, cleared for G. Dundas Co. on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 4 510(k) clearances for G. Dundas Co., from to . As of , FDA records show no recalls naming K802591.

Clearance record

Decision date
Received
(22 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
G. Dundas Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BSZ

Trailing 12 months
2 clearances under product code BSZ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260