Atlas FDA

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

CJM · Predicate Candidate Screening

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

78 daysmedian FDA review time
187 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IImmunodiagnostic Systems , Ltd.2015-04-211870
K130321LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISODiasorin2013-04-09600
K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute Diagnostics2005-06-01650
K032188NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute Diagnostics2003-07-31140
K943397DSL ACTIVE ALDOSTERONE RIA (DSL 8600)Diagnostic Systems Laboratories, Inc.1995-02-132140
K921205DSL ACTIVE ALDOSTERONE (DSL 8600)Diagnostic Systems Laboratories, Inc.1992-07-101200
K862204RSL (125I) ALDOSTERONE KITRadioassay Systems Laboratories, Inc.1986-09-251070
K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITSerono Laboratories, Inc.1984-03-02780
K831178COAT-A-COUNT NO-EXTRACTION ALDOSTERONEDiagnostic Products Corp.1983-05-27460
K800775ALDOCTK-125Sorin Biomedica, Fiat, USA, Inc.1980-04-21140
K781504125I-ALDOSTERONE RIA DIAG. KITAbbott Laboratories1978-11-22840
K771526125 I ALDOSTERONE RIA KITDiagnostic Products Corp.1977-08-25170

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