Cleared Traditional

K010598 - SYNOVIALSCOPICS

K010598 is the FDA 510(k) clearance for SYNOVIALSCOPICS by Quantimetrix Corp.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K010598 · Quantimetrix Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
23d
Days
Class 2
Risk

K010598 is an FDA 510(k) clearance for the SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on March 23, 2001 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K010598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2001
Decision Date March 23, 2001
Days to Decision 23 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
90d faster than avg
Panel avg: 113d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 105
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K010598.
PARA 5X
K011410 · Streck Laboratories, Inc. · Jun 2001
R & D 4K RETIC
K010470 · R&D Systems, Inc. · May 2001
ADVIA RETIC PLUS
K010461 · R&D Systems, Inc. · Apr 2001
CBC-SF
K010409 · R&D Systems, Inc. · Mar 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · Beckman Coulter, Inc. · Feb 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · Beckman Coulter, Inc. · Feb 2001