PARADIGM 1.5ML RESERVOIR, MODEL 326— 510(k) K001828
Substantially EquivalentMinimed, Inc.
FDA 510(k) clearance K001828 for PARADIGM 1.5ML RESERVOIR, MODEL 326, Substantially Equivalent on 2000-08-18. Applicant: Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Minimed, 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
- Sylmar, CA, US
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)
More clearances from Minimed, Inc.
view all- K031541 — PARADIGMPAL, MODEL MMT-7330
- K031390 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
- K030531 — MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
- K021974 — MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
- K010377 — MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
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 K001828
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001828.
Data sourced from openFDA. This site is unofficial and independent of the FDA.