Cleared Traditional

K871830 - NAPSAC(TM)

K871830 is an FDA 510(k) clearance for NAPSAC(TM), manufactured by Beecher Medical Diagnostic Instrumentation. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K871830

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.

GKL Device Classification - Class 2, Special Controls

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 99
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