Cleared Abbreviated

ASTOFLO (K020060) - FDA 510(k) Clearance

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020060 · Nats Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
56d
Days
Class 2
Risk

K020060 is an FDA 510(k) clearance for the ASTOFLO. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Nats Corp. (Sound Beach, US). The FDA issued a Cleared decision on March 5, 2002 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9205 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nats Corp. devices

Submission Details

510(k) Number K020060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2002
Decision Date March 05, 2002
Days to Decision 56 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code BSB Warmer, Blood, Non-electromagnetic Radiation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9205
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.