LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE— 510(k) K042800
Substantially EquivalentHospira, Inc.
FDA 510(k) clearance K042800 for LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE, Substantially Equivalent on 2004-10-18. Applicant: Hospira, Inc.. Device class: 2.
Clearance details
- Applicant
- Hospira, Inc.
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
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More clearances from Hospira, Inc.
view allAdverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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 K042800
K-number listed on FDA's recall record- Z-2141-2016 — LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.
- Z-2873-2016 — LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
- Z-2874-2016 — LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
- Z-1518-2015 — The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042800.
Data sourced from openFDA. This site is unofficial and independent of the FDA.