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

Nemectron Medical, Inc. — Predicate Candidate Screening

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

104 daysmedian FDA review time
320 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K923396THERMODYNNemectron Medical, Inc.1993-05-263200
K895000NEMECTRON MICROWAVENemectron Medical, Inc.1990-07-273530
K862376NEMECTROSON MODEL 2Nemectron Medical, Inc.1986-07-23290
K854720NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.Nemectron Medical, Inc.1986-03-101080
K854721NEMECTRODYN MODEL 2 & ENDOVAC 2Nemectron Medical, Inc.1986-03-061040
K844416THERMOPULS ENemectron Medical, Inc.1985-03-121180
K843734NEMDINemectron Medical, Inc.1984-10-25310
K843735SOFTEPILNemectron Medical, Inc.1984-10-25310
K823511EMG BIOFEEDBACK DEVICENemectron Medical, Inc.1983-03-311220
K820334NEMECTRODYN MODELS 8,7,5 (VOLS. I-IVNemectron Medical, Inc.1982-03-15380
K810513ELECTRODYN CII-INTERFERENTIAL MUSCLENemectron Medical, Inc.1981-05-11760
K802804NEMECTRODYN 8Nemectron Medical, Inc.1981-03-161310
K802805NEMECTRODYN 5Nemectron Medical, Inc.1980-11-0500

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