Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
W.O.M. World of Medicine GmbH · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
738 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2025-12-05 | 266 | 0 |
| K201361 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2020-07-29 | 68 | 0 |
| K173311 | ARTHRO-Pump PA304 | W.O.M. World of Medicine GmbH | 2018-05-09 | 203 | 0 |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | 2018-03-28 | 135 | 0 |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | 2018-02-05 | 215 | 1 |
| K170784 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2017-05-15 | 61 | 0 |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | 2017-03-21 | 118 | 0 |
| K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016-03-04 | 88 | 0 |
| K152109 | HD-Camera HDC1000 | W.O.M. World of Medicine GmbH | 2015-10-13 | 76 | 0 |
| K011175 | W.O.M. LASER U100 | W.O.M. World of Medicine GmbH | 2001-11-01 | 198 | 0 |
| K000153 | ARTHRO-SURGIMAT-A103 | W.O.M. World of Medicine GmbH | 2000-02-08 | 21 | 0 |
| K990732 | LAP-WAVE 3000 (P07) | W.O.M. World of Medicine GmbH | 1999-07-23 | 140 | 0 |
| K990443 | ARTHRO-SURGIMAT-2000 ECU | W.O.M. World of Medicine GmbH | 1999-02-26 | 15 | 0 |
| K983889 | HYS-SURGIFLATOR 150P | W.O.M. World of Medicine GmbH | 1999-01-14 | 73 | 0 |
| K983910 | ARTHRO-SURGIMAT-1500 | W.O.M. World of Medicine GmbH | 1998-11-25 | 22 | 0 |
| K981859 | SURGIFLATOR-20 ECU | W.O.M. World of Medicine GmbH | 1998-06-26 | 30 | 0 |
| K973432 | SURGIFLATOR-30 | W.O.M. World of Medicine GmbH | 1997-12-09 | 90 | 0 |
| K955791 | SURGIFLATOR-20 PIM | W.O.M. World of Medicine GmbH | 1996-12-17 | 361 | 0 |
| K962114 | ARTHRO-SURGIMAT | W.O.M. World of Medicine GmbH | 1996-08-22 | 83 | 0 |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | 1995-12-08 | 73 | 0 |
| K934866 | HYS-SURGIMAT | W.O.M. World of Medicine GmbH | 1995-10-20 | 738 | 0 |
| K933847 | HYS-SURGIFLATOR VP | W.O.M. World of Medicine GmbH | 1995-08-15 | 739 | 0 |
| K924523 | HYS-SURGIFLATOR | W.O.M. World of Medicine GmbH | 1995-04-11 | 945 | 0 |
| K926259 | SURGIMAT | W.O.M. World of Medicine GmbH | 1994-09-14 | 635 | 0 |
| K935763 | SURGIPUMP | W.O.M. World of Medicine GmbH | 1994-04-21 | 146 | 0 |
| K921264 | SURGIFLATOR | W.O.M. World of Medicine GmbH | 1992-10-09 | 207 | 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