Cleared Traditional

K811697 - GUAMSTAINER

K811697 is the FDA 510(k) clearance for GUAMSTAINER by Tomtec. It is a Class 1 Microbiology device (product code KPA) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K811697 · Tomtec · Microbiology device
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Jul 1981
Decision
16d
Days
Class 1
Risk

K811697 is an FDA 510(k) clearance for the GUAMSTAINER. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Tomtec (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.3800 - the FDA microbiology 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.

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Submission Details

510(k) Number K811697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1981
Decision Date July 02, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
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 - KPA Slide Stainer, Automated

Devices cleared under the same product code (KPA) and FDA review panel - the closest regulatory comparables to K811697.
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · Fisher Scientific Co., LLC · Sep 1987
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
K850157 · Shaban Mfg. Co. · Feb 1985
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
K850333 · Shaban Mfg. Co. · Feb 1985
TECHNICON AUTOSLIDE STAINING/PROCESSING
K781598 · Technicon Instruments Corp. · Oct 1978
AUTO. SLIDE STAINER
K780017 · Honeywell, Inc. · Jan 1978
HEMA-TEK II SLIDE STAINER
K771559 · Miles Laboratories, Inc. · Aug 1977