Cleared Traditional

K011283 - MONOJECT PREFILL 0.9% SODIUM CHLORIDE F...

K011283 is an FDA 510(k) clearance for MONOJECT PREFILL 0.9% SODIUM CHLORIDE F..., manufactured by The Kendall Company. The device is a Class 2 General Hospital device with product code NGT cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K011283 · The Kendall Company · General Hospital
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Oct 2001
Decision
171d
Days
Class 2
Risk

K011283 is an FDA 510(k) clearance for the MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by The Kendall Company (Mansfield, US). The FDA issued a Cleared decision on October 15, 2001 after a review of 171 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 The Kendall Company devices

FDA 510(k) Submission Details - K011283

510(k) Number K011283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2001
Decision Date October 15, 2001
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NGT Device Classification - Class 2, Special Controls

Product Code NGT Saline, Vascular Access Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.
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.