Cleared Traditional

K921005 - AUTOLOADER

K921005 is an FDA 510(k) clearance for AUTOLOADER, manufactured by Innovative Medical Systems, Inc.. The device is a Class 1 Hematology device with product code JQW cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K921005 · Innovative Medical Systems, Inc. · Hematology device
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Apr 1992
Decision
57d
Days
Class 1
Risk

K921005 is an FDA 510(k) clearance for the AUTOLOADER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2750 - 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.

FDA 510(k) Submission Details - K921005

510(k) Number K921005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date April 29, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 113d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K921005.
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K913809 · Hyperion, Inc. · Jan 1992
K921005 · AUTOLOADER
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