CARE-E-VAC 3— 510(k) K062610

Name: FDA 510(k) clearance K062610
Creator: U.S. Food and Drug Administration
Published: 2006-09-28

Substantially Equivalent

Ohio Medical Corporation

FDA 510(k) clearance K062610 for CARE-E-VAC 3, Substantially Equivalent on 2006-09-28. Applicant: Ohio Medical Corporation. Device class: 2.

Clearance details

Applicant: Ohio Medical Corporation
Product code: Code BTA
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2006-09-05
Decision date: 2006-09-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Gurnee, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTA

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More clearances from Ohio Medical Corporation

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K081185 — MOBLVAC W.C.2008-05-02

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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 K062610

K-number listed on FDA's recall record

Z-2995-2018 — Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.Class II·Terminated·Ohio Medical Corporation·20180814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062610.

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