W.O.M. World of Medicine GmbH: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “W.O.M. World of Medicine GmbH” (first 1992, latest 2025), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 126 days. Since 2017 the median was 135 days, against 93 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 76 |
| 2016 | 1 | 88 |
| 2017 | 2 | 90 |
| 2018 | 3 | 203 |
| 2019 | 0 | — |
| 2020 | 1 | 68 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 266 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name W.O.M. World of Medicine GmbH took a median 135 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | 7 | 7 |
| HIG | Insufflator, Hysteroscopic | 6 | 6 |
| HRX | Arthroscope | 6 | 6 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| DQI | Withdrawal/Infusion Pump | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
Review panels
- Obstetrics and Gynecology (16)
- Orthopedic (6)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent W.O.M. World of Medicine GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250795 | PUREVUE FMS | HRX | 2025-12-05 | 266 |
| K201361 | PNEUMOCLEAR | HIF | 2020-07-29 | 68 |
| K173311 | ARTHRO-Pump PA304 | HRX | 2018-05-09 | 203 |
| K173489 | GYN-Pump PH304 | HIG | 2018-03-28 | 135 |
| K172040 | Aquilex Fluid Control System AQL-100S | HIG | 2018-02-05 | 215 |
| K170784 | PNEUMOCLEAR | HIF | 2017-05-15 | 61 |
| K163320 | LAP-Pump PP110 | HET | 2017-03-21 | 118 |
| K153513 | Insufflator 50L FM134 | HIF | 2016-03-04 | 88 |
| K152109 | HD-Camera HDC1000 | FET | 2015-10-13 | 76 |
| K011175 | W.O.M. LASER U100 | GEX | 2001-11-01 | 198 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named W.O.M. World of Medicine GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under W.O.M. World of Medicine GmbH (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via DQI)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via DQI)
Frequently asked questions
How many FDA 510(k) clearances are listed under W.O.M. World of Medicine GmbH?
FDA lists 26 510(k) clearances under the applicant name “W.O.M. World of Medicine GmbH” (first 1992, latest 2025), across 8 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by W.O.M. World of Medicine GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name W.O.M. World of Medicine GmbH is 126 days. Since 2017: 135 days, versus 93 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under W.O.M. World of Medicine GmbH?
The most frequent FDA product codes under this applicant name are HIF (Insufflator, Laparoscopic, 7); HIG (Insufflator, Hysteroscopic, 6); HRX (Arthroscope, 6).
Next steps
- See all 26 W.O.M. World of Medicine GmbH clearances with predicates and recalls
- Run predicate analysis for product code HIF, W.O.M. World of Medicine GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.