510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875011Substantially Equivalent

Dey-Pak Purified Water, Usp, Sterile

Dey Laboratories, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875011 is the FDA 510(k) clearance record for DEY-PAK PURIFIED WATER, USP, STERILE, a class I device, cleared for Dey Laboratories, Inc. on under FDA product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)). FDA records list 6 510(k) clearances for Dey Laboratories, Inc., from to . As of , FDA records show no recalls naming K875011.

Clearance record

Decision date
Received
(49 days to decision)
Product code
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Regulation
21 CFR 868.5640
Device class
Class I
Review panel
Anesthesiology
Applicant
Dey Laboratories, Inc. 1011 Detroit Ave., Concord CA
Third party review
No

Clearances, product code CCQ

Trailing 12 months

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

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