MINIMED 508 INSULIN PUMP— 510(k) K990801
Substantially Equivalent - Subject to Tracking Reg.Medtronic Minimed
FDA 510(k) clearance K990801 for MINIMED 508 INSULIN PUMP, Substantially Equivalent - Subject to Tracking Reg. on 1999-06-08. Applicant: Medtronic Minimed. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Sylmar, CA, US
Recent devices under product code LZG
view allMore clearances from Medtronic Minimed
view allAdverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
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 K990801
K-number listed on FDA's recall record- Z-1581-2020 — MiniMed Insulin Pump, model # MMT-508
- Z-0177-2020 — Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990801.
Data sourced from openFDA. This site is unofficial and independent of the FDA.