PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES— 510(k) K120065
Substantially EquivalentPlaxtron Industrial (M) Sdn. Bhd.
FDA 510(k) clearance K120065 for PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES, Substantially Equivalent on 2012-04-03. Applicant: Plaxtron Industrial (M) Sdn. Bhd.. Device class: 2.
Clearance details
- Applicant
- Plaxtron Industrial (M) Sdn. Bhd.
- Product code
- Code JCX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kaohsiung City, TW
Recent devices under product code JCX
view allAdverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
Source: openFDA MAUDE database, through . 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 K120065
K-number listed on FDA's recall record- Z-1341-2026 — Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
- Z-0868-2021 — Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
- Z-0973-2018 — LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120065.
Data sourced from openFDA. This site is unofficial and independent of the FDA.