Cleared Traditional

K001462 - CARESIDE HEMOGLOBIN

K001462 is an FDA 510(k) clearance for CARESIDE HEMOGLOBIN, manufactured by Careside, Inc.. The device is a Class 2 Hematology device with product code KHG cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K001462 · Careside, Inc. · Hematology device
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Aug 2000
Decision
103d
Days
Class 2
Risk

K001462 is an FDA 510(k) clearance for the CARESIDE HEMOGLOBIN. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on August 21, 2000 after a review of 103 days - within the typical 510(k) review window.

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 Careside, Inc. devices

FDA 510(k) Submission Details - K001462

510(k) Number K001462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date August 21, 2000
Days to Decision 103 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 113d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHG Device Classification - Class 2, Special Controls

Product Code KHG Whole Blood Hemoglobin Determination
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.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 30
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K001462.
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