Cleared Traditional

K850157 - CANNULAS FOR HEMA-TEK I & KK SLIDE STAI...

K850157 is the FDA 510(k) clearance for CANNULAS FOR HEMA-TEK I & KK SLIDE STAI... by Shaban Mfg. Co.. It is a Class 1 Hematology device (product code KPA) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K850157 · Shaban Mfg. Co. · Hematology device
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Feb 1985
Decision
43d
Days
Class 1
Risk

K850157 is an FDA 510(k) clearance for the CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Shaban Mfg. Co. (Fort Myers, US). The FDA issued a Cleared decision on February 27, 1985 after a review of 43 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 Shaban Mfg. Co. devices

Submission Details

510(k) Number K850157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1985
Decision Date February 27, 1985
Days to Decision 43 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
70d faster than avg
Panel avg: 113d · This submission: 43d
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 K850157.
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · Fisher Scientific Co., LLC · Sep 1987
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