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

Respironics California, Inc. · Predicate Candidate Screening

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

103 daysmedian FDA review time
367 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV Respironics California, Inc.2012-01-133670
K110795V200 INTELLI-TRAK OPTIONRespironics California, Inc.2011-08-191500
K102054V200 VENTILATORRespironics California, Inc.2010-12-221530
K082660V60 VENTILATOR, MODEL V8000Respironics California, Inc.2009-01-0911921
K072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000Respironics California, Inc.2007-12-121030
K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000Respironics California, Inc.2007-07-30900
K051262ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000Respironics California, Inc.2005-07-08531
K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL VRespironics California, Inc.2004-06-18226
K034032PLV CONTINUUM VENTILATOR, MODEL P2000Respironics California, Inc.2004-03-16780
K022750PLV CONTINUUM VENTILATOR, MODEL P1000Respironics California, Inc.2003-11-204582
K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSRespironics California, Inc.2002-11-06307

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