Cleared Traditional

K821186 - PENETRAK TM

K821186 is the FDA 510(k) clearance for PENETRAK TM by Syva Co.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K821186 · Syva Co. · Hematology device
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Jun 1982
Decision
59d
Days
Class 2
Risk

K821186 is an FDA 510(k) clearance for the PENETRAK TM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Syva Co. devices

Submission Details

510(k) Number K821186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date June 25, 1982
Days to Decision 59 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 113d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K821186.
COULTER COUNTER MODEL S-PLUS V
K833600 · Coulter Electronics, Inc. · Jan 1984
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
K831271 · Ortho Diagnostic Systems, Inc. · Jul 1983
COULTER-COUNTER #S PLUS IV & LYSE S +D
K823355 · Coulter Electronics, Inc. · Dec 1982
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · Abbott Laboratories · Jan 1981
ADD OF RETICULOCYTE COUNT/CAPABILITIES
K800533 · Abbott Laboratories · Apr 1980
TECHNICON C/90 SYSTEM
K800121 · Technicon Instruments Corp. · Feb 1980