510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160589Substantially Equivalent

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Certa Dose, Dever CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160589 is the FDA 510(k) clearance record for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe, a class II device, cleared for Certa Dose, Inc. on under FDA product code PQX (Epinephrine Syringe). FDA's definition for product code PQX reads: "Intended for intramuscular or subcutaneous injection of epinephrine". FDA records list 2 510(k) clearances for Certa Dose, Inc., from to . As of , FDA records show no recalls naming K160589.

Clearance record

Decision date
Received
(324 days to decision)
Product code
PQX Epinephrine Syringe
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Certa Dose, Inc. 573 Race St., Dever CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQX

Trailing 12 months

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

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