Cleared Traditional

K955719 - SICKLE-2000

K955719 is an FDA 510(k) clearance for SICKLE-2000, manufactured by Medicus Technologies, Inc.. The device is a Class 2 Hematology device with product code GIQ cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K955719 · Medicus Technologies, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
240d
Days
Class 2
Risk

K955719 is an FDA 510(k) clearance for the SICKLE-2000. Classified as Hemoglobin S (product code GIQ), Class II - Special Controls.

Submitted by Medicus Technologies, Inc. (West Chester, US). The FDA issued a Cleared decision on August 14, 1996 after a review of 240 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - 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 Medicus Technologies, Inc. devices

FDA 510(k) Submission Details - K955719

510(k) Number K955719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date August 14, 1996
Days to Decision 240 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
127d slower than avg
Panel avg: 113d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIQ Device Classification - Class 2, Special Controls

Product Code GIQ Hemoglobin S
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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.