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

Pegasus Research Corp. — Predicate Candidate Screening

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

176 daysmedian FDA review time
728 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122857HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER Pegasus Research Corp.2012-11-07500
K020700PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPYPegasus Research Corp.2004-04-267840
K013856PMH 1000 HEATED HUMIDIFIERPegasus Research Corp.2003-02-214720
K983783HEATED HUMIDIFIERPegasus Research Corp.2000-10-247280
K962534THERA-MIST NEBULIZER MODEL-P3000Pegasus Research Corp.1997-02-282450
K946057AQUALARM MOISTURE SENSOR MODEL P85000Pegasus Research Corp.1995-05-051440
K915890AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIEDPegasus Research Corp.1992-06-241830
K914465AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000Pegasus Research Corp.1992-03-311760
K903489THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000Pegasus Research Corp.1990-12-101300
K894000THERA-MIST HUMIDIFIERPegasus Research Corp.1989-08-28840
K893942THERA-MIST(TM) NEBULIZER, MODEL 30000Pegasus Research Corp.1989-08-28890
K880473AERO-MIST NEBULIZER HEATERPegasus Research Corp.1988-03-31560

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