Cleared Traditional

K871830 - NAPSAC(TM)

K871830 is the FDA 510(k) clearance for NAPSAC(TM) by Beecher Medical Diagnostic Instrumentation. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K871830 · Beecher Medical Diagnostic Instrumentation · Hematology device
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Sep 1987
Decision
121d
Days
Class 2
Risk

K871830 is an FDA 510(k) clearance for the NAPSAC(TM). Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Beecher Medical Diagnostic Instrumentation (Silver Spring, US). The FDA issued a Cleared decision on September 9, 1987 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Beecher Medical Diagnostic Instrumentation devices

Submission Details

510(k) Number K871830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date September 09, 1987
Days to Decision 121 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 113d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 69
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K871830.
RETICCOUNT SOFTWARE
K880636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
CELLECT LABTRAK SOFTWARE
K874320 · Instrumentation Laboratory CO · Jan 1988
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
TECHNICON H*1 JR.(TM) SYSTEM
K873103 · Technicon Instruments Corp. · Aug 1987
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374 · Instrumentation Laboratory CO · Sep 1986
COULTER COUNTER MODEL T-890
K863084 · Coulter Electronics, Inc. · Sep 1986