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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medisense, Inc. · Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

95 daysmedian FDA review time
211 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983504PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISIOMedisense, Inc.1999-07-092761
K982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DMedisense, Inc.1998-12-081600
K983253PRECISION A1C HOME HBA1C SAMPLE COLLECTION KITMedisense, Inc.1998-11-20650
K971812PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLMedisense, Inc.1997-08-08840
K963676PRECISION G BLOOD GLUCOSE TESTING SYSTEMMedisense, Inc.1997-02-201600
K962295PRECISION QID BLOOD GLUCOSE TEST STRIPMedisense, Inc.1996-07-26710
K961337EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEMMedisense, Inc.1996-06-21740
K952279PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEMMedisense, Inc.1995-06-14640
K944195QUICKPRO BLOOD GLUCOSE TESTING SYSTEMMedisense, Inc.1995-03-232060
K945887PRECISION Q I D BLOOD GLUCOSE TEST STRIPSMedisense, Inc.1995-03-231120
K901613MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEMMedisense, Inc.1990-07-10950
K896467SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEMMedisense, Inc.1990-06-122110
K897118SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEMMedisense, Inc.1990-05-101350
K897110SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEMMedisense, Inc.1990-02-27630
K896951SATELLITE G BLOOD GLUCOSE MONITORING SYSTEMMedisense, Inc.1990-02-26730

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda