Cleared Traditional

K843821 - SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS

K843821 is an FDA 510(k) clearance for SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS, manufactured by Solco Basle, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 368-day FDA review.

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

FDA 510(k) Submission Details - K843821

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
228d slower than avg
Panel avg: 140d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

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 168
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K843821.
BT-795/P AUTOMATED AUTOTRANS
K860306 · Electromedics, Inc. · Mar 1986
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
K852178 · American Omni Medical, Inc. · Dec 1985
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM
K854301 · Deknatel, Inc. · Nov 1985
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
K851024 · Pfizer, Inc. · May 1985
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · American Bentley · Dec 1983