Name: Predicase
Price: 199 USD

K-number	K250792
Device name	t:slim X2 insulin pump with interoperable technology
Applicant	Tandem Diabetes Care, Inc.
Product code	QFG
Device class	Class II
Decision date	Sep 24, 2025
Decision	Substantially Equivalent
Regulation	880.5730

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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t:slim X2 insulin pump with interoperable technology

Everything you need for a 510(k) submission. Nothing you don't.