H-TRON V 100 INSULIN INFUSION PUMP— 510(k) K905693

Name: FDA 510(k) clearance K905693
Creator: U.S. Food and Drug Administration
Published: 1991-04-12

Substantially Equivalent

Disetronic Medical Systems

FDA 510(k) clearance K905693 for H-TRON V 100 INSULIN INFUSION PUMP, Substantially Equivalent on 1991-04-12. Applicant: Disetronic Medical Systems. Device class: 2.

Clearance details

Applicant: Disetronic Medical Systems
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1990-12-19
Decision date: 1991-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZG

view all

K262153 — Pivot Insulin Delivery System2026-09-02
K253534 — Pivot Insulin Delivery System2026-04-08
K240158 — Modular Medical MODD1 Insulin Delivery System2024-09-04
K241622 — Extended Reservoir; MiniMed Reservoir2024-07-02
K223372 — Omnipod GO Insulin Delivery Device2023-04-24

More clearances from Disetronic Medical Systems

view all

K013782 — DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE2001-11-20
K994186 — DISETRONIC D-TRON INSULIN INFUSION PUMP1999-12-30
K994197 — DISENTRONIC PENFINE INJECTION PEN NEEDLE1999-12-29
K993666 — DISETRONIC PEN P1001999-11-22
K991376 — DAHEDI INSULIN INFUSION PUMP1999-06-15

Adverse 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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.