ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump— 510(k) K162165
Substantially EquivalentSummit Medical Products, Inc.
FDA 510(k) clearance K162165 for ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump, Substantially Equivalent on 2017-08-29. Applicant: Summit Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Summit Medical Products, 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
- Sandy, UT, US
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More clearances from Summit Medical Products, 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 K162165
K-number listed on FDA's recall record- Z-1684-2023 — AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
- Z-1685-2023 — AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
- Z-1686-2023 — SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
- Z-1687-2023 — SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
- Z-1688-2023 — ambIT Cassette Filter Male Luer, Product Code: 220266
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162165.
Data sourced from openFDA. This site is unofficial and independent of the FDA.