Cleared Traditional

K122023 - MIXJECT WITH SPRAY HEAD

K122023 is an FDA 510(k) clearance for MIXJECT WITH SPRAY HEAD, manufactured by Medimop Medical Projects, Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K122023 · Medimop Medical Projects, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
85d
Days
Class 2
Risk

K122023 is an FDA 510(k) clearance for the MIXJECT WITH SPRAY HEAD. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medimop Medical Projects, Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on October 4, 2012 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medimop Medical Projects, Ltd. devices

FDA 510(k) Submission Details - K122023

510(k) Number K122023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2012
Decision Date October 04, 2012
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Peers - FMF Syringe, Piston

All 388
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K122023.
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MERIT MEDICAL 20 ML SYRINGE
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