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

Nikomed U.S.A., Inc. · Predicate Candidate Screening

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

276 daysmedian FDA review time
284 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022909NIKOMED TRACE 1 ECG ELECTRODESNikomed U.S.A., Inc.2003-01-091280
K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc.2000-02-04242
K950473DISPOSABLE ECG MONITORING ELECTRODENikomed U.S.A., Inc.1995-12-123120
K950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540Nikomed U.S.A., Inc.1995-11-142840
K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MMNikomed U.S.A., Inc.1995-11-142840
K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MMNikomed U.S.A., Inc.1995-11-062760
K950471DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MMNikomed U.S.A., Inc.1995-11-062760
K950477DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MMNikomed U.S.A., Inc.1995-11-062760
K950478DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MMNikomed U.S.A., Inc.1995-11-062760
K950474DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MMNikomed U.S.A., Inc.1995-11-062760
K950470DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MMNikomed U.S.A., Inc.1995-11-062760
K950479DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MMNikomed U.S.A., Inc.1995-09-132220
K950476DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MMNikomed U.S.A., Inc.1995-09-062150
K90289649-610 NIKO-NOSE FIXATION TAPENikomed U.S.A., Inc.1990-10-231120
K872793DP-700 NIKMAN DEFIB-PADSNikomed U.S.A., Inc.1987-10-09870

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