Cleared Traditional

K865101 - SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM

K865101 is an FDA 510(k) clearance for SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM, manufactured by Spectramed, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K865101 · Spectramed, Inc. · Cardiovascular device
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Apr 1987
Decision
111d
Days
Class 2
Risk

K865101 is an FDA 510(k) clearance for the SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Spectramed, Inc. (St. Louis Park, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectramed, Inc. devices

FDA 510(k) Submission Details - K865101

510(k) Number K865101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1986
Decision Date April 20, 1987
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 112
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K865101.
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