510(k) K031383 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
MODEL 780
| Applicant | Hudson Respiratory Care, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Jul 7, 2003 |
| Received | May 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2026 | Medline Industries, LP Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit Open, Classified |
BTT | None listed |
| Dec 15, 2015 | Teleflex Medical Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column Terminated |
BTT | None listed |
| Jul 23, 2014 | Teleflex Medical Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respi Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.