Cleared Traditional

K812892 - S/P SERUM DROPPER PIPETS (FDA 510(k) Clearance)

Class I Hematology device.

K812892 · American Dade · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
12d
Days
Class 1
Risk

K812892 is an FDA 510(k) clearance for the S/P SERUM DROPPER PIPETS. Classified as Supplies, Blood-bank (product code KSS), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on October 27, 1981 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9050 - 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 Dade devices

Submission Details

510(k) Number K812892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1981
Decision Date October 27, 1981
Days to Decision 12 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 113d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KSS Supplies, Blood-bank
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.9050
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.