Cleared Traditional

K983022 - SMARTCELL PROCESSING SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983022 · Harvest Technologies, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
214d
Days
Class 2
Risk

K983022 is an FDA 510(k) clearance for the SMARTCELL PROCESSING SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Harvest Technologies, LLC (Norwell, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 214 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Harvest Technologies, LLC devices

Submission Details

510(k) Number K983022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1998
Decision Date April 02, 1999
Days to Decision 214 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 139d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 194
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K983022.
XTRA Collection sets
K241236 · Sorin Group Italia S.R.L. · Aug 2024
Aventus Clot Management System
K240426 · Inquis Medical · May 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · Sorin Group Italia S.R.L. · Apr 2024
FlowSaver Blood Return System (80-101)
K231782 · Inari Medical, Inc. · Jul 2023
FlowSaver Blood Return System
K221483 · Inari Medical, Inc. · Feb 2023
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · Haemonetics Corporation · Nov 2022