Dornier Medtech America, Inc.: FDA clearances and approvals
Dornier Medtech America, Inc. has 46 FDA 510(k) clearances (first 1990, latest 2025), plus 3 PMA decisions, across 12 product codes in 4 review panels. Median 510(k) review time: 87 days. Since 2017 its median was 140 days, against 98 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Dornier Medtech America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 42 |
| 2013 | 4 | 84 |
| 2014 | 1 | 383 |
| 2015 | 3 | 28 |
| 2016 | 1 | 30 |
| 2017 | 2 | 98 |
| 2018 | 1 | 27 |
| 2019 | 3 | 270 |
| 2020 | 2 | 138 |
| 2021 | 1 | 98 |
| 2022 | 2 | 162 |
| 2023 | 1 | 237 |
| 2024 | 1 | 268 |
| 2025 | 1 | 50 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dornier Medtech America, Inc.'s cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 25 | 25 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 9 | 8 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 5 | 5 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 2 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 1 | 1 |
| MEQ | System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | 1 | 0 |
Plus 2 more product codes.
Review panels
Most recent Dornier Medtech America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | FED | 2025-01-31 | 50 |
| K233380 | TRIDENT Mobile Fluoroscopy System | JAA | 2024-06-26 | 268 |
| K221903 | Delta III Pro | LNS | 2023-02-22 | 237 |
| K213252 | Dornier Thulio | GEX | 2022-07-27 | 300 |
| K220871 | Nautilus | JAA | 2022-04-18 | 24 |
| K210394 | Electrosurgical accessory | FAS | 2021-05-19 | 98 |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | FED | 2020-11-20 | 142 |
| K201074 | Delta III Lithotripter | LNS | 2020-09-03 | 134 |
| K190612 | EQUINOX Balloon Dilatation Catheter | EZN | 2019-12-06 | 270 |
| K190312 | Dornier Ureteral Stent | FAD | 2019-11-15 | 276 |
36 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000048 | PMA | DORNIER EPOS ULTRA | 2002-01-15 |
| P970044 | PMA | DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM | 1998-05-29 |
| P840008 | PMA | DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) | 1984-12-19 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-04-01.
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.
Frequently asked questions
How many FDA 510(k) clearances does Dornier Medtech America, Inc. have?
Dornier Medtech America, Inc. has 46 FDA 510(k) clearances (first 1990, latest 2025), plus 3 PMA decisions, across 12 product codes in 4 review panels.
How long does FDA take to clear Dornier Medtech America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dornier Medtech America, Inc.'s cleared 510(k)s is 87 days. Since 2017: 140 days, versus 98 days for all cleared 510(k)s in the same product codes.
What devices does Dornier Medtech America, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 25); LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 9); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 5).
Has Dornier Medtech America, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Dornier Medtech America, Inc; the most recent began 2019-04-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 46 Dornier Medtech America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Dornier Medtech America, Inc.'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.