Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Disetronic Medical Systems · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
418 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013782 | DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE | Disetronic Medical Systems | 2001-11-20 | 6 | 0 |
| K994186 | DISETRONIC D-TRON INSULIN INFUSION PUMP | Disetronic Medical Systems | 1999-12-30 | 20 | 0 |
| K994197 | DISENTRONIC PENFINE INJECTION PEN NEEDLE | Disetronic Medical Systems | 1999-12-29 | 16 | 0 |
| K993666 | DISETRONIC PEN P100 | Disetronic Medical Systems | 1999-11-22 | 21 | 0 |
| K991376 | DAHEDI INSULIN INFUSION PUMP | Disetronic Medical Systems | 1999-06-15 | 55 | 1 |
| K990259 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | Disetronic Medical Systems | 1999-02-12 | 16 | 0 |
| K982966 | DISETRONIC PEN | Disetronic Medical Systems | 1998-10-19 | 55 | 0 |
| K982399 | DISETRONIC PENFINE INJECTION PEN NEEDLE | Disetronic Medical Systems | 1998-08-06 | 27 | 0 |
| K973339 | DISETRONIC PENFINE INJECTION PEN NEEDLE | Disetronic Medical Systems | 1997-09-24 | 19 | 0 |
| K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP | Disetronic Medical Systems | 1997-09-15 | 31 | 5 |
| K961975 | DISETRONIC D-MODEM | Disetronic Medical Systems | 1997-01-30 | 255 | 0 |
| K954826 | DISETRONIC MULTIFUSE PUMP SYSTEM | Disetronic Medical Systems | 1996-05-24 | 217 | 0 |
| K943952 | DISETRONIC D-MODEM | Disetronic Medical Systems | 1995-10-07 | 418 | 0 |
| K920063 | DISETRONIC DOLOMAT PUMP | Disetronic Medical Systems | 1993-08-03 | 574 | 0 |
| K915566 | DISETRONIC PANOMAT PUMP | Disetronic Medical Systems | 1992-08-07 | 239 | 2 |
| K913891 | DISETRONIC(R) INFUSOR | Disetronic Medical Systems | 1992-03-27 | 210 | 0 |
| K905693 | H-TRON V 100 INSULIN INFUSION PUMP | Disetronic Medical Systems | 1991-04-12 | 114 | 1 |
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