Cleared Traditional

K970419 - DAXOR MAX100 SYRINGE (MAX100)

K970419 is an FDA 510(k) clearance for DAXOR MAX100 SYRINGE (MAX100), manufactured by Daxor Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 321-day FDA review.

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

FDA 510(k) Submission Details - K970419

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
192d slower than avg
Panel avg: 129d · This submission: 321d
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 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K970419.
BECTON DICKINSON SYRINGE
K980987 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · Terumo Medical Corp. · Apr 1998
B-D E ML PEN
K980755 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1998
DRESSING CHANGE TRAYS
K963260 · Busse Hospital Disposables, Inc. · Nov 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · Terumo Medical Corp. · May 1996
BECTON DICKINSON SYRINGSE
K954064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995