Cleared Traditional

K933836 - HBM HEMOGLOBINOMETER

K933836 is an FDA 510(k) clearance for HBM HEMOGLOBINOMETER, manufactured by Artel, Inc.. The device is a Class 2 Hematology device with product code GIG cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K933836 · Artel, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
238d
Days
Class 2
Risk

K933836 is an FDA 510(k) clearance for the HBM HEMOGLOBINOMETER. Classified as Hemoglobinometer (product code GIG), Class II - Special Controls.

Submitted by Artel, Inc. (Windham, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 238 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Artel, Inc. devices

FDA 510(k) Submission Details - K933836

510(k) Number K933836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1993
Decision Date March 31, 1994
Days to Decision 238 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 113d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIG Device Classification - Class 2, Special Controls

Product Code GIG Hemoglobinometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 Hematology devices follow this clearance model.