W.O.M. World of Medicine GmbH: FDA clearances and approvals
W.O.M. World of Medicine GmbH has 26 FDA 510(k) clearances (first 1992, latest 2025), across 8 product codes in 5 review panels. Median 510(k) review time: 126 days. Since 2017 its median was 135 days, against 93 days for all cleared 510(k)s in the same product codes.
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, W.O.M. World of Medicine GmbH's cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of W.O.M. World of Medicine GmbH's product codes (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 does W.O.M. World of Medicine GmbH have?
W.O.M. World of Medicine GmbH has 26 FDA 510(k) clearances (first 1992, latest 2025), across 8 product codes in 5 review panels.
How long does FDA take to clear W.O.M. World of Medicine GmbH's 510(k)s?
The median time from FDA receipt to decision across W.O.M. World of Medicine GmbH's cleared 510(k)s is 126 days. Since 2017: 135 days, versus 93 days for all cleared 510(k)s in the same product codes.
What devices does W.O.M. World of Medicine GmbH make?
Its most frequent FDA product codes are HIF (Insufflator, Laparoscopic, 7); HIG (Insufflator, Hysteroscopic, 6); HRX (Arthroscope, 6).
Has W.O.M. World of Medicine GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching W.O.M. World of Medicine GmbH. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.