Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
W.O.M. World of Medicine AG · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
325 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123732 | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | 2013-04-04 | 120 | 0 |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | 2012-02-06 | 147 | 0 |
| K063367 | 45L CORE INSUFFLATOR, MODEL F114 | W.O.M. World of Medicine AG | 2007-05-23 | 197 | 1 |
| K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | W.O.M. World of Medicine AG | 2006-12-14 | 121 | 1 |
| K060723 | 40 L HIGH FLOW INSUFFLATOR F113 | W.O.M. World of Medicine AG | 2006-05-25 | 69 | 0 |
| K042457 | URO PRO | W.O.M. World of Medicine AG | 2004-10-25 | 45 | 1 |
| K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | W.O.M. World of Medicine AG | 2004-02-05 | 325 | 0 |
| K033927 | ARTHOSCOPY PUMP A115 | W.O.M. World of Medicine AG | 2004-01-15 | 28 | 0 |
| K032023 | W.O.M. LASER U100PLUS | W.O.M. World of Medicine AG | 2003-10-01 | 93 | 0 |
| K022721 | UROPOWER | W.O.M. World of Medicine AG | 2003-08-26 | 375 | 0 |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | 2003-08-13 | 82 | 0 |
| K030402 | ARTHROSCOPY PUMP, MODEL A107 | W.O.M. World of Medicine AG | 2003-04-17 | 70 | 0 |
| K022449 | HYSTEREOSCOPY PUMP HM4 | W.O.M. World of Medicine AG | 2003-04-10 | 258 | 0 |
| K023041 | W.O.M. LASER U100 | W.O.M. World of Medicine AG | 2002-12-11 | 90 | 0 |
| K021686 | LASER FIBER GF500 | W.O.M. World of Medicine AG | 2002-08-20 | 90 | 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