Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Weinmann Gerate Fur Medizin GmbH + Co. KG · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
190 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112167 | SOYALA SILKGEL FULL FACE MASK | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-11-16 | 111 | 0 |
| K110884 | EASYFIT SILKGEL NASAL MASK | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-07-12 | 104 | 0 |
| K102515 | NP15 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-03-11 | 190 | 0 |
| K081014 | SOYALA GEL VENTED | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-05-09 | 30 | 0 |
| K073673 | SOYALA FULL FACE MASK GEL VENTED | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-03-28 | 92 | 0 |
| K072009 | WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-12-14 | 144 | 0 |
| K071163 | WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-07-18 | 83 | 0 |
| K061653 | SOYALA FULL FACE MASK | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-11-09 | 149 | 0 |
| K060405 | SOYALA, SOYALA BLUE | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-06-21 | 125 | 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