Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

3D Line USA, Inc. — Predicate Candidate Screening

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

196 daysmedian FDA review time

245 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K034051	DYNATRAC, COD. 50-1A	3D Line USA, Inc.	2004-04-05	97	0
K031281	ERGO SRS	3D Line USA, Inc.	2003-12-23	245	0
K031631	STEREOTACTIC BODY FRAME, MODEL COD. 70-1A	3D Line USA, Inc.	2003-07-18	52	0
K013535	EVTOOL MODEL # V. 1.0	3D Line USA, Inc.	2002-01-18	87	0
K011255	3D LINE STEROTACTIC HARDWARE ACCESSORIES	3D Line USA, Inc.	2001-12-20	240	2
K001163	DMLC IV-ERGO	3D Line USA, Inc.	2000-10-23	196	2

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