Cleared Traditional

HEMESPEC II (K803015) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K803015 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
32d
Days
Class 2
Risk

K803015 is an FDA 510(k) clearance for the HEMESPEC II. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 30, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 Helena Laboratories devices

Submission Details

510(k) Number K803015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1980
Decision Date December 30, 1980
Days to Decision 32 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
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 38
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K803015.
HemoCue Hb 301 System
K201217 · Hemocue AB · Aug 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · Ekf Diagnostic GmbH · Jun 2020
HemoCue Hb 801 System
K181751 · Hemocue AB · Feb 2019
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995