510(k) Report

FDA applicant

Medisense, Inc.

Waltham, MA15 decisions1990–19991 recall

FDA records 15 decisions for Medisense, Inc. (Waltham, MA) from 1990 to 1999: 15 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 27 predicates, 17 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Medisense, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medisense, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medisense, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medisense, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CGAGlucose Oxidase, Glucose11decisions
  • LCPAssay, Glycosylated Hemoglobin1decision
  • LDPColorimetry, Acetaminophen1decision
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision
  • CEMElectrode, Ion Specific, Potassium1decision

Whose devices does it build on?

Its devices cite 27 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 17 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 19956cite it
  • K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra…Medisense, Inc. · 19996cite it
  • K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 19964cite it
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 19974cite it
  • K944195Quickpro Blood Glucose Testing SystemMedisense, Inc. · 19953cite it
  • K963676Precision G Blood Glucose Testing SystemMedisense, Inc. · 19973cite it

What has FDA decided for it lately?

  • K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra…Medisense, Inc. · 19991 recall
  • K982303Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood…Medisense, Inc. · 1998
  • K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc. · 1998
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997
  • K963676Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  • K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  • K961337Exactech RSG Blood Glucose Testing SystemMedisense, Inc. · 1996
  • K952279Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995

All 15 as Medisense, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K983504Precision PCx Test Strips Part Number: 98757-12Nov 8, 2002