Atlas FDA

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

Diacor, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
217 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121929ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.2013-01-171990
K050888INTEGRA IMMOBILIZATION SYSTEMDiacor, Inc.2005-05-23460
K954414CENTRALITE BACKPOINTERDiacor, Inc.1995-10-23320
K953046PERI-PUSHERDiacor, Inc.1995-09-22840
K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.1995-08-162170
K934566RADASSISTDiacor, Inc.1993-11-03430
K930246MAMMORXDiacor, Inc.1993-07-261880
K893398CENTRALITE BACKPOINTERDiacor, Inc.1989-08-171080
K872489CENTRALITEDiacor, Inc.1987-07-15220
K860193PORTALCASTDiacor, Inc.1986-01-3080

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