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

Dantec Electronics, Inc. — Predicate Candidate Screening

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

161 daysmedian FDA review time
286 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K895460CONCENTRIC ELECTRODE TYPE #13R01, 13R02Dantec Electronics, Inc.1990-06-182850
K894911SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118Dantec Electronics, Inc.1990-05-142860
K884915DANTEC 22K60/61/62 CATHETER TIP TRANSDUCERDantec Electronics, Inc.1989-10-043100
K881915DANTEC MAGNETIC STIMULATORDantec Electronics, Inc.1988-10-171610
K874758DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODEDantec Electronics, Inc.1988-04-141480
K87475913L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLEDantec Electronics, Inc.1988-04-141480
K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODEDantec Electronics, Inc.1988-01-22650
K870567EVOPORT 300Dantec Electronics, Inc.1987-10-062380
K872106DANTEC COUNTERPOINTDantec Electronics, Inc.1987-09-101010
K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.1986-04-23790
K853119URODYN 1000Dantec Electronics, Inc.1985-10-04710
K843815EVOMATIC 8000/4000Dantec Electronics, Inc.1985-05-312450

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