ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP— 510(k) K081905
Substantially EquivalentWestmed, Inc.
FDA 510(k) clearance K081905 for ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP, Substantially Equivalent on 2008-07-15. Applicant: Westmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Westmed, Inc.
- Product code
- Code MEB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Highlands Ranch, CO, US
Recent devices under product code MEB
view allMore clearances from Westmed, Inc.
view allAdverse events under product code MEB
product code MEB- Death
- 6
- Injury
- 160
- Malfunction
- 10,053
- Other
- 5
- Total
- 10,224
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 K081905
K-number listed on FDA's recall record- Z-2655-2014 — B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
- Z-0921-2014 — B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
- Z-0161-2013 — Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081905.
Data sourced from openFDA. This site is unofficial and independent of the FDA.