Cleared Traditional

K970419 - DAXOR MAX100 SYRINGE (MAX100) (FDA 510(k) Clearance)

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

K970419 · Daxor Corporation · General Hospital
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Dec 1997
Decision
321d
Days
Class 2
Risk

K970419 is an FDA 510(k) clearance for the DAXOR MAX100 SYRINGE (MAX100). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Daxor Corporation (Knoxville, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 321 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 Daxor Corporation devices

Submission Details

510(k) Number K970419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date December 22, 1997
Days to Decision 321 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 128d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 748
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