Cleared Traditional

K780017 - AUTO. SLIDE STAINER

K780017 is an FDA 510(k) clearance for AUTO. SLIDE STAINER, manufactured by Honeywell, Inc.. The device is a Class 1 Hematology device with product code KPA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K780017 · Honeywell, Inc. · Hematology device
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Jan 1978
Decision
27d
Days
Class 1
Risk

K780017 is an FDA 510(k) clearance for the AUTO. SLIDE STAINER. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3800 - 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K780017

510(k) Number K780017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1978
Decision Date January 30, 1978
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

KPA Device Classification - Class 1, General Controls

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 K780017.
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
HEMA-TEK II SLIDE STAINER
K771559 · Miles Laboratories, Inc. · Aug 1977