Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dornier Medtech America, Inc. · Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
300 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | 2023-02-22 | 237 | 0 |
| K213252 | Dornier Thulio | Dornier Medtech America, Inc. | 2022-07-27 | 300 | 0 |
| K220871 | Nautilus | Dornier Medtech America, Inc. | 2022-04-18 | 24 | 0 |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | 2021-05-19 | 98 | 0 |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | 2020-11-20 | 142 | 0 |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2020-09-03 | 134 | 0 |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | 2019-12-06 | 270 | 0 |
| K190312 | Dornier Ureteral Stent | Dornier Medtech America, Inc. | 2019-11-15 | 276 | 0 |
| K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | 2019-09-18 | 138 | 0 |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2017-08-08 | 29 | 0 |
| K161771 | Medilas H Laser Fibers | Dornier Medtech America, Inc. | 2016-07-28 | 30 | 0 |
| K152591 | Medilas H RFID Laser Fibers | Dornier Medtech America, Inc. | 2015-10-08 | 28 | 0 |
| K151485 | GENESIS | Dornier Medtech America, Inc. | 2015-06-30 | 28 | 0 |
| K133434 | GENESIS II | Dornier Medtech America, Inc. | 2014-11-26 | 383 | 0 |
| K130344 | DORNIER MEDILAS UROPULSE | Dornier Medtech America, Inc. | 2013-03-21 | 38 | 0 |
| K122159 | DORNIER MEDILAS H30 SOLVO | Dornier Medtech America, Inc. | 2013-02-01 | 196 | 0 |
| K122768 | GENESIS | Dornier Medtech America, Inc. | 2013-01-18 | 130 | 0 |
| K123385 | MEDILAS H LASER FIBERS | Dornier Medtech America, Inc. | 2012-12-14 | 42 | 0 |
| K121656 | GEMINI LITHOTRIPTER | Dornier Medtech America, Inc. | 2012-09-24 | 111 | 0 |
| K121938 | MEDILAS H RFID LASER FIBER | Dornier Medtech America, Inc. | 2012-08-01 | 30 | 0 |
| K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 | Dornier Medtech America, Inc. | 2011-12-07 | 303 | 0 |
| K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEB | Dornier Medtech America, Inc. | 2009-02-12 | 79 | 0 |
| K083258 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEB | Dornier Medtech America, Inc. | 2009-01-30 | 87 | 0 |
| K073427 | MEDILAS D FAMILY LASERS | Dornier Medtech America, Inc. | 2008-08-20 | 258 | 0 |
| K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 | Dornier Medtech America, Inc. | 2008-06-27 | 85 | 0 |
| K070536 | MEDILAS D FAMILY LASERS | Dornier Medtech America, Inc. | 2007-05-21 | 84 | 0 |
| K070123 | TCA 5R / 5S | Dornier Medtech America, Inc. | 2007-03-09 | 52 | 0 |
| K061455 | DORNIER MEDILAS H 20 LASER | Dornier Medtech America, Inc. | 2006-08-01 | 68 | 0 |
| K020339 | DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & | Dornier Medtech America, Inc. | 2002-10-25 | 266 | 0 |
| K022544 | DORNIER MEDILAS H LASER FIBER CABLES | Dornier Medtech America, Inc. | 2002-08-21 | 20 | 0 |
| K021724 | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, ME | Dornier Medtech America, Inc. | 2002-08-19 | 87 | 0 |
| K011322 | DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDP | Dornier Medtech America, Inc. | 2001-11-19 | 202 | 0 |
| K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER | Dornier Medtech America, Inc. | 2001-04-17 | 209 | 0 |
| K983963 | DORNIER MEDILA H | Dornier Medtech America, Inc. | 1998-11-25 | 19 | 0 |
| K964760 | DORNIER MEDILAS FIBER TOME LASER | Dornier Medtech America, Inc. | 1997-02-19 | 84 | 0 |
| K955019 | UROTRACT I | Dornier Medtech America, Inc. | 1995-12-06 | 34 | 0 |
| K921549 | DORNIER FIBERTOME 100 WATT SURGICAL LASER | Dornier Medtech America, Inc. | 1993-02-18 | 323 | 0 |
| K913191 | DORNIER LASER LITHOTRIPTER IMPACT | Dornier Medtech America, Inc. | 1991-10-16 | 90 | 0 |
| K904149 | FLEXISYS | Dornier Medtech America, Inc. | 1990-12-04 | 88 | 0 |
| K904155 | MEDILAS 4060N FIBERTOM(R) SURGICAL LASER | Dornier Medtech America, Inc. | 1990-11-21 | 75 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda