Atlas FDA

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

Dynatech/Nevada, Inc. — Predicate Candidate Screening

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

129 daysmedian FDA review time
241 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942546CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZERDynatech/Nevada, Inc.1995-01-272410
K935817MEDSIM 300 PATIENT SIMULATORDynatech/Nevada, Inc.1994-01-18470
K934254IMPULSE 3000 DEFIBRILLATOR ANALYZERDynatech/Nevada, Inc.1993-11-23840
K897074MODEL 215M PATIENT SIMULATORDynatech/Nevada, Inc.1990-05-171460
K897029MODEL ECG100 SIMULATORDynatech/Nevada, Inc.1990-04-261290
K897096MODEL 404A I.V. INFUSION PUMP ANALYZERDynatech/Nevada, Inc.1990-03-15840

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