Atlas FDA

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

BZW — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time
88 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.1988-01-29880
K860558ESOPHAGEAL STETHOSCOPESharn, Inc.1986-04-01460
K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.1985-01-10550
K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.1984-08-24180
K842865ESOPHAGEAL STETHOSCOPEInmed Corp.1984-08-15230
K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.1984-08-151200
K830329ESOPHAGEAL STETHOSCOPEScience Development Corp.1983-03-11380
K830218SHERIDAN/ESOPHAGEAL STETHOSCOPESheridan Catheter Corp.1983-03-09440
K823703ESOPHAGEAL STETHOSCOPERsp, Inc.1983-01-07290
K823126MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIERElectromedics, Inc.1982-11-16220
K800463ESOPHAGEAL STETHESCOPEMedical Components, Inc.1980-03-10100
K790523ARGYLE ESOPHAGEAL STETHOSCOPESherwood Medical Industries1979-03-27120
K771411ESOPHAGEAL STETH. TEMP. SENSORLabarge, Inc.1977-09-23530

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