Atlas FDA

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

Acudata Software — Predicate Candidate Screening

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

129 daysmedian FDA review time
240 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900596ACUDATA INDICATENS MODEL 5AAcudata Software1990-06-221340
K900668ACUDATA INDICATENS MODEL 5XSAcudata Software1990-06-221290
K890087ACUDATA INDICATENS MODEL 5MAcudata Software1989-09-072400
K890088ACUDATA INDICATENS MODEL 5XAcudata Software1989-05-261360
K891105INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHESAcudata Software1989-05-25840
K891107INDICATENS INDICATOR ELECTRODE MODEL 2Acudata Software1989-05-25840
K881708INDICATENS 4X4Acudata Software1988-08-111130

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