Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DLF — Predicate Candidate Screening

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

28 daysmedian FDA review time
50 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881607EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647Em Diagnostic Systems, Inc.1988-06-01500
K850174TDX ETHOSUXIMIDEAbbott Laboratories1985-02-06200
K844204EMIT QST ETHOSUXIMIDE ASSAYSyva Co.1984-12-11420
K832797MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.1983-09-29420
K823801AMES TDA ETHOSUXIMIDE TESTMiles Laboratories, Inc.1983-01-14280
K823745ADVANCE EMIT-AED ETHOSUXIMIDESyva Co.1983-01-07250
K792584ACA ETHOSURIMIDE TEST PACKE.I. Dupont DE Nemours & Co., Inc.1979-12-31170
K780461ANALYZER-SUPPLEMENT, KINETIC, LKB 2086Syva Co.1978-04-12200
K780380ANALYZER, FAST, CENTRIFUGAL, GEMSAECSyva Co.1978-04-12330

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