INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM— 510(k) K062700
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K062700 for INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM, Substantially Equivalent on 2006-10-26. Applicant: B.Braun Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- B.Braun Medical, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allentown, PA, US
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More clearances from B.Braun Medical, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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 K062700
K-number listed on FDA's recall record- Z-0623-2013 — Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
- Z-1992-2012 — Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062700.
Data sourced from openFDA. This site is unofficial and independent of the FDA.