Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Accu-Chek Safe-T-Pro Uno Lancing Device

K-Number: K220364 · 2022-04-05

ApplicantRoche Diabetes Care, Inc.
Decision Date2022-04-05
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Accu-Chek Safe-T-Pro Uno Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-04-05 under 510(k) number K220364. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accu-Chek Safe-T-Pro Uno Lancing Device?

Accu-Chek Safe-T-Pro Uno Lancing Device is a medical device that received FDA 510(k) clearance on 2022-04-05. The listed applicant is Roche Diabetes Care, Inc.. The 510(k) number is K220364.

When did Accu-Chek Safe-T-Pro Uno Lancing Device receive FDA 510(k) clearance?

Accu-Chek Safe-T-Pro Uno Lancing Device received FDA 510(k) clearance on 2022-04-05, under 510(k) number K220364.

Who is the listed applicant for Accu-Chek Safe-T-Pro Uno Lancing Device?

The FDA 510(k) record lists Roche Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accu-Chek Safe-T-Pro Uno Lancing Device?

The FDA product code for Accu-Chek Safe-T-Pro Uno Lancing Device is FMK.

Other records listing Roche Diabetes Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232509Accu-Chek Safe-T-Pro Uno Lancing DeviceK232488Accu-Chek Safe-T-Pro Plus Lancing DeviceK213134Accu-Chek Solo micropump system with interoperable technologyK213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemK220849Accu-Chek Safe-T-Pro Plus Lancing DeviceK203711IWL2020 Blood Glucose Monitoring System

View all 11 devices →

Related Devices (Code: FMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑