SICNot classified

Tempo Pilot Ckm: Cardio-Kidney-Metabolic

Unknown

SIC is the FDA product code for Tempo Pilot Ckm: Cardio-Kidney-Metabolic. FDA's definition for this code reads: "TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SIC
Device name: Tempo Pilot Ckm: Cardio-Kidney-Metabolic
FDA definition: TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
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 SIC.

Recent clearances

Product code SIC

FDA records hold no clearances under product code SIC.

Recent recalls

Product code SIC

FDA records show no recalls under product code SIC.

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)