# W.O.M. World of Medicine GmbH

- Location (FDA's records): Berlin, DE
- FDA decisions: 41 (1992–2025): 41 510(k) clearances
- Names in FDA's records: W.O.M. World of Medicine GmbH (26); W.O.M. World of Medicine AG (15)
- Product codes: HIF (10), HIG (10), HRX (9), GEX (4), HET (3), LJH (1), DQI (1), EXY (1), FET (1), GEY (1)
- 510(k) review time since 2016: median 135 days, against 107 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 63 (35 its own); citations of its devices by later devices: 60 (35 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Karl Storz Endoscopy: 3 (https://510kreport.com/company/karl-storz-endoscopy)
- W.O.M. GmbH: 3 (https://510kreport.com/company/wom)
- Future Medical Systems, Inc.: 2 (https://510kreport.com/company/future-medical-systems)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Linvatec Corp.: 2 (https://510kreport.com/company/linvatec)
- Surgiquest, Inc.: 2 (https://510kreport.com/company/surgiquest)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Innovaquartz, LLC: 1 (https://510kreport.com/company/innovaquartz)

## Firms that cite its devices most
- Karl Storz SE & CO. KG: 4 (https://510kreport.com/company/karl-storz)
- Lexion Medical, LLC: 3 (https://510kreport.com/company/lexion-medical)
- Conmed Corporation: 2 (https://510kreport.com/company/conmed)
- Meditrina, Inc.: 1 (https://510kreport.com/company/meditrina)
- Smith & Nephew Endoscopy, Inc.: 1 (https://510kreport.com/company/smith-nephew-endoscopy)
- SmartsurgN, Inc.: 1 (https://510kreport.com/company/smartsurgn)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Surgiquest, Inc.: 1 (https://510kreport.com/company/surgiquest)

## Its most-cited devices
- K063367: 45L Core Insufflator, Model F114 (2007), cited by 7
- K030402: Arthroscopy Pump, Model A107 (2003), cited by 5
- K112642: Aquilex Fluid Control System H112 (2012), cited by 5
- K022449: Hystereoscopy Pump HM4 (2003), cited by 4
- K030837: 40 L High Flow Insufflator F108 (2004), cited by 4
- K153513: Insufflator 50L FM134 (2016), cited by 3

## Recent decisions
- K250795: Purevue™ FMS (Dec 5, 2025)
- K201361: Pneumoclear (Jul 29, 2020)
- K173311: ARTHRO-Pump PA304 (May 9, 2018)
- K173489: GYN-Pump PH304 (Mar 28, 2018)
- K172040: Aquilex Fluid Control System AQL-100S (Feb 5, 2018)
- K170784: Pneumoclear (May 15, 2017)
- K163320: LAP-Pump PP110 (Mar 21, 2017)
- K153513: Insufflator 50L FM134 (Mar 4, 2016)

Source page: https://510kreport.com/company/wom-world-of-medicine