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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Dornier Surgical Products, Inc. · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

63 daysmedian FDA review time
154 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003993DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)Dornier Surgical Products, Inc.2001-03-26900
K000072DORNIER MEDILAS D SKINPULSEDornier Surgical Products, Inc.2000-06-121540
K001243DORNIER MEDILAS HDornier Surgical Products, Inc.2000-05-24360
K993146DORNIER SCANNER HANDPIECEDornier Surgical Products, Inc.1999-11-08490
K991183DORNIER LASERTRODE FIBERDornier Surgical Products, Inc.1999-06-09620
K984591DORNIER MEDILAS H/2Dornier Surgical Products, Inc.1999-03-26880
K982629DORNIER MEDILAS DDornier Surgical Products, Inc.1998-09-14480
K981438DORNIER MEDILAS EDornier Surgical Products, Inc.1998-07-20900
K981718DORNIER MEDILAS HDornier Surgical Products, Inc.1998-07-17630

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