Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devilbiss Healthcare, LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
268 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026-03-26 | 132 | 0 |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | 2025-12-09 | 267 | 0 |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | Devilbiss Healthcare, LLC | 2018-03-23 | 203 | 1 |
| K152810 | DeVilbiss DV6WM Wireless Modem | Devilbiss Healthcare, LLC | 2016-01-21 | 115 | 0 |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | Devilbiss Healthcare, LLC | 2015-09-18 | 268 | 0 |
| K140880 | DEVILBISS SMARTLINK II SYSTEM | Devilbiss Healthcare, LLC | 2014-08-04 | 119 | 0 |
| K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL | Devilbiss Healthcare, LLC | 2011-11-22 | 112 | 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