Cleared Traditional

K160589 - Certa Dose PD Epinephrine 1mg/mL IM/SC ...

K160589 is an FDA 510(k) clearance for Certa Dose PD Epinephrine 1mg/mL IM/SC ..., manufactured by Certa Dose, Inc.. The device is a Class 2 General Hospital device with product code PQX cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K160589 · Certa Dose, Inc. · General Hospital
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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.

View all Certa Dose, Inc. devices

FDA 510(k) Submission Details - K160589

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 129d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PQX Device Classification - Class 2, Special Controls

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.