Lifescan, Inc.: FDA filings under this applicant name

FDA lists 42 510(k) clearances under the applicant name “Lifescan, Inc.” (first 1981, latest 2013), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Top product codes

Review panels

• Clinical Chemistry (39)
• Hematology (2)
• General Hospital (1)

Most recent Lifescan, Inc. 510(k) clearances

32 earlier clearances. See the full list in Caduvo.

Recalls

27 product recalls in 22 recall events; 0 initiated in the last five years. Most recent: 2013-03-11.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Lifescan, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03138174: OneTouch Verio Flex System Accuracy Evaluation (Completed, started 2017-03-23)
• NCT02929654: Assessment of Blood Glucose Monitoring Devices With New Insight Features (Completed, started 2016-10-01)
• NCT02767336: Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation (Completed, started 2016-04)
• NCT02429024: Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences (Completed, started 2015-05)
• NCT02374879: User Performance and System Accuracy Evaluations Using Glucose Adjustment (Completed, started 2015-02-01)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Lifescan, Inc. (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via MRZ)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
• E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Lifescan Europe (3 510(k)s)
• Lifescan Europe, A Division of Cilag GmbH (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Lifescan, Inc.?

FDA lists 42 510(k) clearances under the applicant name “Lifescan, Inc.” (first 1981, latest 2013), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Lifescan, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Lifescan, Inc. is 71 days.

Which FDA product codes appear under Lifescan, Inc.?

The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 21); NBW (System, Test, Blood Glucose, Over The Counter, 13); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 3).

Next steps

• See all 42 Lifescan, Inc. clearances with predicates and recalls
• Run predicate analysis for product code CGA, Lifescan, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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