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

Disetronic Medical Systems AG — Predicate Candidate Screening

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

55 daysmedian FDA review time
84 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST Disetronic Medical Systems AG2010-05-146313
K070189ACCU-CHEK ULTRAFLEX INFUSION SETDisetronic Medical Systems AG2007-02-21300
K063146ACCU-CHEK LINKASSISTDisetronic Medical Systems AG2006-11-27420
K060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODisetronic Medical Systems AG2006-06-15761
K042887ACCU-CHEK SPIRITDisetronic Medical Systems AG2005-03-181501
K043000MODIFICATION TO D-TRONPLUSDisetronic Medical Systems AG2004-12-01302
K033892ULTRAFLEX INFUSION SETDisetronic Medical Systems AG2004-03-098412
K023471DISETRONIC H-TRONPLUS INSULIN INFUSION PUMPDisetronic Medical Systems AG2002-10-29141
K022831MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMPDisetronic Medical Systems AG2002-09-11161
K021725DISETRONIC D-TRON INSULIN INFUSION PUMPDisetronic Medical Systems AG2002-08-02700
K003977DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RADisetronic Medical Systems AG2001-02-15550
K001629DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMDisetronic Medical Systems AG2000-06-21260

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