Cleared Traditional

K874918 - IRON PROCEDURE

K874918 is the FDA 510(k) clearance for IRON PROCEDURE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code JIY) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K874918 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
70d
Days
Class 1
Risk

K874918 is an FDA 510(k) clearance for the 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 February 11, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - the FDA in vitro diagnostics and chemistry 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

Submission Details

510(k) Number K874918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1987
Decision Date February 11, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 51
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K874918.
IRON PROCEDURE
K881167 · Data Medical Associates, Inc. · Apr 1988
IRON TEST
K881202 · Sclavo, Inc. · Apr 1988
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
K880467 · Stanbio Laboratory · Mar 1988
WAKO(TM) FE C
K874263 · Wako Chemicals USA, Inc. · Nov 1987
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986 · Beckman Instruments, Inc. · Apr 1987
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
K871284 · American Research Products Co. · Apr 1987