Cleared Traditional

K180683 - Certa Dose Pediatric Midazolam 5mg/mL I...

K180683 is an FDA 510(k) clearance for Certa Dose Pediatric Midazolam 5mg/mL I..., 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 237-day FDA review.

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

FDA 510(k) Submission Details - K180683

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.

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.

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.