Cleared Traditional

K771699 - CARA-STAIN MODEL 3000 (FDA 510(k) Clearance)

Class I Hematology device.

K771699 · American Safety Equipment Corp. · Hematology device
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Sep 1977
Decision
7d
Days
Class 1
Risk

K771699 is an FDA 510(k) clearance for the CARA-STAIN MODEL 3000. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by American Safety Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977 after a review of 7 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 American Safety Equipment Corp. devices

Submission Details

510(k) Number K771699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1977
Decision Date September 13, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 113d · This submission: 7d
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.