Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Daavlin Distributing Co. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
202 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2023-12-13 | 14 | 0 |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023-03-24 | 39 | 0 |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | 2022-04-22 | 30 | 1 |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021-11-04 | 86 | 1 |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021-06-22 | 89 | 1 |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | Daavlin Distributing Co. | 2015-09-10 | 70 | 0 |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | Daavlin Distributing Co. | 2011-10-20 | 202 | 0 |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | Daavlin Distributing Co. | 2011-08-29 | 125 | 0 |
| K100628 | PLASMALUXLS | Daavlin Distributing Co. | 2010-11-24 | 264 | 0 |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERI | Daavlin Distributing Co. | 2010-04-28 | 71 | 0 |
| K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | Daavlin Distributing Co. | 2008-12-17 | 90 | 0 |
| K073587 | DERMAPAL WITH DIGITAL TIMER | Daavlin Distributing Co. | 2008-01-18 | 29 | 0 |
| K050695 | FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT | Daavlin Distributing Co. | 2005-04-19 | 32 | 0 |
| K042502 | 3 SERIES PHOTOTHERAPY CABINET | Daavlin Distributing Co. | 2004-10-14 | 30 | 0 |
| K022104 | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD | Daavlin Distributing Co. | 2002-09-10 | 74 | 0 |
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