Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Nidek Medical Products, Inc. · Predicate Candidate Screening

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

211 daysmedian FDA review time
315 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192693Nuvo Nano Portable Oxygen ConcentratorNidek Medical Products, Inc.2020-05-072240
K123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STDNidek Medical Products, Inc.2013-02-28850
K093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STDNidek Medical Products, Inc.2010-01-14840
K082566MARK 5 NUVO LITE OCSI AND STDNidek Medical Products, Inc.2008-12-03900
K040892MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905Nidek Medical Products, Inc.2004-04-29230
K032509MARK 5 NUVO (M5C5)Nidek Medical Products, Inc.2004-03-182177
K020797PULMO-MIST COMPRESSOR MODEL # 4323Nidek Medical Products, Inc.2002-05-03520
K980551SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEMNidek Medical Products, Inc.1998-11-172780
K962492SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEMNidek Medical Products, Inc.1997-01-232110
K952966CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEMNidek Medical Products, Inc.1996-05-073150
K942593OXYCHEK OXYGEN ANALYZERNidek Medical Products, Inc.1995-05-033360
K883591MARK-5 CONCENTRATORNidek Medical Products, Inc.1988-11-02710

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