AFF (MARK I) VOLUMETRIC INFUSION PUMP— 510(k) K070529
Substantially EquivalentDefinitive Medical Technologies, Ltd.
FDA 510(k) clearance K070529 for AFF (MARK I) VOLUMETRIC INFUSION PUMP, Substantially Equivalent on 2007-05-08. Applicant: Definitive Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Definitive Medical Technologies, Ltd.
- 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
- Lod, IL
Recent devices under product code FRN
view all- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
Adverse 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 K070529
K-number listed on FDA's recall record- Z-2219-2016 — The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
- Z-2220-2016 — The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
- Z-0242-2016 — Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
- Z-1122-2014 — Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070529.
Data sourced from openFDA. This site is unofficial and independent of the FDA.