Atlas FDA

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

Nicolet Instrument Corp. — Predicate Candidate Screening

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

139 daysmedian FDA review time
272 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921138NICOLET ULTRASOM ACQUISITION STATIONNicolet Instrument Corp.1993-05-144300
K923315NICOLET ARK SYSTEMNicolet Instrument Corp.1992-11-231390
K921927NICOLET VOYAGEURNicolet Instrument Corp.1992-11-051950
K915652NICOLET PORATBLE SPIRIT SYSTEMNicolet Instrument Corp.1992-02-07510
K905632NICOLET MAPLELEAF SYSTEMNicolet Instrument Corp.1991-06-071720
K897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLENicolet Instrument Corp.1990-04-301250
K894629NICOLET BEAM II SYSTEMNicolet Instrument Corp.1990-03-092280
K896477NICOLET REAL EAR ANALYZERNicolet Instrument Corp.1990-02-08870
K883781NICOLET NEUROPORT/ACE SYSTEMNicolet Instrument Corp.1989-06-052720
K890495NICOLET VIKING II SYSTEMNicolet Instrument Corp.1989-03-16430
K884294NICOLET NYSTAR PLUS SYSTEMNicolet Instrument Corp.1988-11-23420
K882599NICOLET BRAINLAB SYSTEMNicolet Instrument Corp.1988-10-191170
K882053NICOLET EPIDURAL SPINAL ELECTRODENicolet Instrument Corp.1988-10-181550

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