Cleared Traditional

K950508 - SYSMEX SF-3000

K950508 is the FDA 510(k) clearance for SYSMEX SF-3000 by Sysmex Corp.. It is a Class 2 Hematology device (product code FPK) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K950508 · Sysmex Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
270d
Days
Class 2
Risk

K950508 is an FDA 510(k) clearance for the SYSMEX SF-3000. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Sysmex Corp. (Long Grove, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 270 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 880.5440 - 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 Sysmex Corp. devices

Submission Details

510(k) Number K950508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date November 03, 1995
Days to Decision 270 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
157d slower than avg
Panel avg: 113d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPK Tubing, Fluid Delivery

All 21
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K950508.
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · Medrad, Inc. · Jul 2003
MEDRAD TRANSFER SET
K022431 · Medrad, Inc. · Sep 2002
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · Medtronic Minimed · Feb 1997
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992
LIFESHIELD EXTENSION SET
K912103 · Abbott Laboratories · Dec 1991