Atlas FDA

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

Infimed, Inc. — Predicate Candidate Screening

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

91 daysmedian FDA review time
256 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112180I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)Infimed, Inc.2011-08-10130
K111344I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)Infimed, Inc.2011-06-10290
K103416NEXUS DRF DIGITAL X-RAY IMAGING SYSTEMInfimed, Inc.2011-03-171150
K101833INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5Infimed, Inc.2010-07-23220
K093066I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5Infimed, Inc.2010-03-161670
K012490ORION DIGITAL IMAGING SYSTEMInfimed, Inc.2002-02-121930
K992392RTLXInfimed, Inc.2000-03-312560
K992794STINGRAY DR, MODEL 1Infimed, Inc.1999-11-09820
K992575CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000Infimed, Inc.1999-10-07660
K962422INFIMED DENTAL SYSTEMInfimed, Inc.1997-09-114440
K963037PATRIOTInfimed, Inc.1996-09-27530
K961689INFINETInfimed, Inc.1996-07-31910
K960510THERAVIEWInfimed, Inc.1996-04-22770
K933299QL MULTIPULSE 2048Infimed, Inc.1993-11-031190

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