510(k) K120065 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
| Applicant | Plaxtron Industrial (M) Sdn. Bhd., Kaohsiung City, TW |
| Decision | Substantially Equivalent, Apr 3, 2012 |
| Received | Jan 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2026 | Laerdal Medical Corporation 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; Open, Classified |
JCX | None listed |
| Dec 18, 2020 | Laerdal Medical (Suzhou) Co., Ltd. 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 f Terminated |
JCX | None listed |
| Aug 31, 2017 | Laerdal Medical Corporation 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 Terminated |
JCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.