Cleared Traditional

K950508 - SYSMEX SF-3000

K950508 is an FDA 510(k) clearance for SYSMEX SF-3000, manufactured by Sysmex Corp.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K950508

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
Combination Product No
PCCP Authorized No
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.

FPK Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K950508.
MEDRAD TRANSFER SET
K022431 · Medrad, Inc. · Sep 2002
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · Medtronic Minimed · Feb 1997
SILCLEAR TUBING (MODIFICATION)
K953864 · Degania Silicone , Ltd. · Nov 1995
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
SILCLEAR TUBING
K943992 · Degania Silicone , Ltd. · Mar 1995
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992