Atlas FDA

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

Bio-Research Associates, Inc. · Predicate Candidate Screening

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

137 daysmedian FDA review time
267 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130158M-SCANBio-Research Associates, Inc.2013-07-251830
K082927BIOEMG IIIBio-Research Associates, Inc.2009-02-061280
K061799QUADRATENS, MODEL QT-42Bio-Research Associates, Inc.2006-08-28630
K003176BIOEMG II AND BIOJVABio-Research Associates, Inc.2001-01-04850
K9917563 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPEBio-Research Associates, Inc.1999-12-102000
K981563BIOPAK MEASUREMENT SYSTEMBio-Research Associates, Inc.1998-09-151370
K952218JT-3 ELECTROGNATHOGRAPHBio-Research Associates, Inc.1995-09-211330
K873947BIO-EMG MODEL 800Bio-Research Associates, Inc.1988-04-272120
K844618BIO-TENSBio-Research Associates, Inc.1985-08-212670
K822565NEEDLE CATHETER JEJUNOSTOMY KITBio-Research Associates, Inc.1982-09-28370

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