Cleared Traditional

K862701 - SURESPOT

K862701 is the FDA 510(k) clearance for SURESPOT by Helena Laboratories. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K862701 · Helena Laboratories · Chemistry device
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Aug 1986
Decision
35d
Days
Class 1
Risk

K862701 is an FDA 510(k) clearance for the SURESPOT. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - the FDA in vitro diagnostics and chemistry 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 K862701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1986
Decision Date August 19, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQW Station, Pipetting And Diluting, For Clinical Use

All 63
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K862701.
SMI MULTIPETTOR(TM)
K863887 · American Dade · Nov 1986
ULTRAWASH I
K863623 · Dynatech Laboratories, Inc. · Oct 1986
ULTRAWASH II
K863624 · Dynatech Laboratories, Inc. · Oct 1986
POSID SAMPLER
K860508 · Organon Teknika Corp. · May 1986
DADE BLOOD GAS AMPUL INJECTOR
K852285 · American Dade · Jul 1985
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · Ventrex Laboratories, Inc. · Jun 1985