Cleared Traditional

K160589 - Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160589 · Certa Dose, Inc. · General Hospital
Jan 2017
Decision
324d
Days
Class 2
Risk

K160589 is an FDA 510(k) clearance for the Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe. Classified as Epinephrine Syringe (product code PQX), Class II - Special Controls.

Submitted by Certa Dose, Inc. (Dever, US). The FDA issued a Cleared decision on January 19, 2017 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K160589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date January 19, 2017
Days to Decision 324 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 169d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PQX Epinephrine Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition Intended For Intramuscular Or Subcutaneous Injection Of Epinephrine.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.