Cleared Traditional

K843821 - SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS (FDA 510(k) Clearance)

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

K843821 · Solco Basle, Inc. · Anesthesiology device
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Oct 1985
Decision
368d
Days
Class 2
Risk

K843821 is an FDA 510(k) clearance for the SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Solco Basle, Inc. (Walker, US). The FDA issued a Cleared decision on October 1, 1985 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Solco Basle, Inc. devices

Submission Details

510(k) Number K843821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date October 01, 1985
Days to Decision 368 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 139d · This submission: 368d
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 K843821.
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