Cleared Traditional

K944462 - DMA IRON PROCEDURE

K944462 is an FDA 510(k) clearance for DMA IRON PROCEDURE, manufactured by Data Medical Associates, Inc.. The device is a Class 1 Toxicology device with product code JIY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K944462 · Data Medical Associates, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
64d
Days
Class 1
Risk

K944462 is an FDA 510(k) clearance for the DMA IRON PROCEDURE. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1410 - the FDA toxicology 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 Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K944462

510(k) Number K944462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date November 15, 1994
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

JIY Device Classification - Class 1, General Controls

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIY Photometric Method, Iron (non-heme)

All 61
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K944462.
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OLYMPUS IRON REAGENT
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