Cleared Traditional

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe (K180683) - FDA 510(k) Clearance

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

K180683 · Certa Dose, Inc. · General Hospital
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Nov 2018
Decision
237d
Days
Class 2
Risk

K180683 is an FDA 510(k) clearance for the Certa Dose Pediatric Midazolam 5mg/mL IM Syringe. Classified as Epinephrine Syringe (product code PQX), Class II - Special Controls.

Submitted by Certa Dose, Inc. (Denver, US). The FDA issued a Cleared decision on November 7, 2018 after a review of 237 days - an extended review cycle.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K180683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date November 07, 2018
Days to Decision 237 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 129d · This submission: 237d
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.

Regulatory Consultant

Epstein Becker & Green, P.C.
James A. Boiani

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.