# Dornier Medtech America, Inc.

- Location (FDA's records): Kennesaw, GA
- FDA decisions: 49 (1984–2025): 46 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Dornier Medtech America, Inc. (43); Dornier Medtech America (6)
- Product codes: GEX (25), LNS (9), JAA (5), FED (2), MEQ (1), NBN (1), FAS (1), EZN (1), FAD (1), OWB (1), KQS (1), EYB (1)
- 510(k) review time since 2016: median 140 days, against 119 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 67 (28 its own); citations of its devices by later devices: 56 (28 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dornier Surgical Products, Inc.: 14 (https://510kreport.com/company/dornier-surgical-products)
- Lumenis, Inc.: 4 (https://510kreport.com/company/lumenis)
- Diomed, Inc.: 3 (https://510kreport.com/company/diomed)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Dornier: 2 (https://510kreport.com/company/dornier)
- Biolitec, Inc.: 2 (https://510kreport.com/company/biolitec)
- Well Lead Medical Co., Ltd.: 1 (https://510kreport.com/company/well-lead-medical)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Dornier Surgical Products, Inc.: 3 (https://510kreport.com/company/dornier-surgical-products)
- Dornier: 3 (https://510kreport.com/company/dornier)
- Intermedic Arfran, SA: 2 (https://510kreport.com/company/intermedic-arfran)
- Direx Systems Corp.: 2 (https://510kreport.com/company/direx-systems)
- Dornier Medtech Systems: 2 (https://510kreport.com/company/dornier-medtech-systems)
- Quanta System Spa: 2 (https://510kreport.com/company/quanta-system)
- Lite-Med, Inc.: 2 (https://510kreport.com/company/lite-med)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)

## Its most-cited devices
- P840008: Dornier Lithotripter Compact Transportable (DLCT) (1984), cited by 7
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), cited by 5
- K002929: Dornier Compact Alpha Lithotripter (2001), cited by 5
- K122768: Genesis (2013), cited by 3
- K964760: Dornier Medilas Fiber Tome Laser (1997), cited by 3
- K022544: Dornier Medilas H Laser Fiber Cables (2002), cited by 3

## Recent decisions
- 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 (Jan 31, 2025)
- K233380: TRIDENT Mobile Fluoroscopy System (Jun 26, 2024)
- K221903: Delta III Pro (Feb 22, 2023)
- K213252: Dornier Thulio (Jul 27, 2022)
- K220871: Nautilus (Apr 18, 2022)
- K210394: Electrosurgical accessory (May 19, 2021)
- K201815: Dornier MAGELLAN Ureteral Access Sheath (Nov 20, 2020)
- K201074: Delta III Lithotripter (Sep 3, 2020)

Source page: https://510kreport.com/company/dornier-medtech-america