T:SLIM INSULIN DELIVERY SYSTEM— 510(k) K133593

Name: FDA 510(k) clearance K133593
Creator: U.S. Food and Drug Administration
Published: 2014-03-24

Substantially Equivalent

Tandem Diabetes Care, Inc.

FDA 510(k) clearance K133593 for T:SLIM INSULIN DELIVERY SYSTEM, Substantially Equivalent on 2014-03-24. Applicant: Tandem Diabetes Care, Inc.. Device class: 2.

Clearance details

Applicant: Tandem Diabetes Care, Inc.
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2013-11-22
Decision date: 2014-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Philedelphia, PA, US

Download summary PDF View on FDA.gov ↗

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K241622 — Extended Reservoir; MiniMed Reservoir2024-07-02
K223372 — Omnipod GO Insulin Delivery Device2023-04-24

More clearances from Tandem Diabetes Care, Inc.

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K250792 — t:slim X2 insulin pump with interoperable technology2025-09-24
K250798 — Control-IQ+ technology2025-05-21
K243823 — Control-IQ+ technology2025-02-24

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.