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

Hudson Respiratory Care, Inc. — Predicate Candidate Screening

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

91 daysmedian FDA review time
239 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K031383MODEL 780Hudson Respiratory Care, Inc.2003-07-07672
K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMHudson Respiratory Care, Inc.2001-06-13610
K011134OXYGEN SUPPLY TUBING, MODEL 1115Hudson Respiratory Care, Inc.2001-06-13610
K010402SMOOTH-FLO CIRCUITHudson Respiratory Care, Inc.2001-03-14300
K001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, Hudson Respiratory Care, Inc.2000-11-032030
K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRHudson Respiratory Care, Inc.2000-05-242311
K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896Hudson Respiratory Care, Inc.2000-03-22900
K964719HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATORHudson Respiratory Care, Inc.1997-02-21881
K961150DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULAHudson Respiratory Care, Inc.1996-09-101720
K961914BACTERIA/VIRAL FILTERHudson Respiratory Care, Inc.1996-08-14890
K955645CATH-GUIDEHudson Respiratory Care, Inc.1996-03-12910
K944301HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR Hudson Respiratory Care, Inc.1994-12-211060
K923946CONCHATHERM IV HEATED MOLECULAR HUMIDIFIERHudson Respiratory Care, Inc.1994-10-188040
K930525MICRO MIST(TM) NEBULIZERHudson Respiratory Care, Inc.1993-09-292390
K903083NEONATAL VENTILATOR CIRCUITHudson Respiratory Care, Inc.1990-12-271680

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