Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vapotherm, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
462 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254078 | HVT 2.0 | Vapotherm, Inc. | 2026-04-13 | 116 | 0 |
| K221318 | HVT 2.0 | Vapotherm, Inc. | 2022-12-13 | 221 | 0 |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | 2022-10-28 | 217 | 0 |
| K203357 | HVT 2.0 | Vapotherm, Inc. | 2021-08-25 | 282 | 0 |
| K191010 | Palladium High Flow Therapy System | Vapotherm, Inc. | 2019-10-10 | 177 | 0 |
| DEN170001 | Precision Flow® HVNI | Vapotherm, Inc. | 2018-04-10 | 462 | 0 |
| K111640 | PRECISION FLOW(R) - HELIOX | Vapotherm, Inc. | 2011-10-07 | 116 | 1 |
| K103316 | FLOWREST | Vapotherm, Inc. | 2011-02-08 | 90 | 0 |
| K072845 | PRECISION FLOW | Vapotherm, Inc. | 2008-07-17 | 287 | 8 |
| K070056 | VAPOTHERM MODEL# 2000I AND 2000H | Vapotherm, Inc. | 2007-04-13 | 98 | 0 |
| K042245 | VAPOTHERM MODEL#2000I, 200H | Vapotherm, Inc. | 2004-08-30 | 11 | 0 |
| K013486 | VAPOTHERM 2000H | Vapotherm, Inc. | 2003-05-30 | 588 | 0 |
| K000401 | VAPOTHERM, MODEL 2000I | Vapotherm, Inc. | 2000-08-24 | 199 | 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