SIBNot classified

Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic

Unknown

SIB is the FDA product code for Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic. FDA's definition for this code reads: "TEMPO Pilot: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SIB
Device name: Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic
FDA definition: TEMPO Pilot: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SIB.

Recent clearances

Product code SIB

FDA records hold no clearances under product code SIB.

Recent recalls

Product code SIB

FDA records show no recalls under product code SIB.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)