AUTOTRANS BT795— 510(k) K812292

Name: FDA 510(k) clearance K812292
Creator: U.S. Food and Drug Administration
Published: 1981-10-23

Substantially Equivalent

Electromedics, Inc.

FDA 510(k) clearance K812292 for AUTOTRANS BT795, Substantially Equivalent on 1981-10-23. Applicant: Electromedics, Inc.. Device class: 2.

Clearance details

Applicant: Electromedics, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1981-08-13
Decision date: 1981-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

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K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
K240426 — Aventus Clot Management System2024-05-14
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
K231782 — FlowSaver Blood Return System (80-101)2023-07-14
K221483 — FlowSaver Blood Return System2023-02-17

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K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR1993-07-01
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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K812292

K-number listed on FDA's recall record

Z-0786-2019 — SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.Class II·Ongoing·Medtronic Perfusion Systems·20181127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K812292.

Data sourced from openFDA. This site is unofficial and independent of the FDA.