Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unomedical A/S — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
156 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210544 | Medtronic Extended infusion set | Unomedical A/S | 2021-07-16 | 142 | 0 |
| K192647 | neria guard Infusion Set | Unomedical A/S | 2019-12-13 | 80 | 0 |
| K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | 2018-03-05 | 74 | 0 |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Com | Unomedical A/S | 2017-11-01 | 391 | 5 |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniM | Unomedical A/S | 2016-08-10 | 156 | 0 |
| K132142 | NERIA SOFT 90 INFUSION SET | Unomedical A/S | 2013-10-08 | 89 | 0 |
| K120337 | I-PORT ADVANCE INJECTION PORT | Unomedical A/S | 2012-02-16 | 13 | 0 |
| K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION | Unomedical A/S | 2007-04-04 | 50 | 0 |
| K061374 | INTUITION INFUSION SETS | Unomedical A/S | 2006-07-31 | 75 | 0 |
| K051264 | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH AB | Unomedical A/S | 2005-09-01 | 108 | 1 |
| K041545 | CONTACT DETACH | Unomedical A/S | 2004-06-30 | 21 | 1 |
| K040633 | CLICK-ON | Unomedical A/S | 2004-04-01 | 22 | 0 |
| K032854 | UNOMEDICAL MONICA INFUSION SET | Unomedical A/S | 2003-10-09 | 27 | 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