510(k) Report

FDA applicant

Hudson Respiratory Care, Inc.

Temecula, CA15 decisions1990–20036 recalls

FDA records 15 decisions for Hudson Respiratory Care, Inc. (Temecula, CA) from 1990 to 2003: 15 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 10 predicates, 1 of them its own earlier devices. 6 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Hudson Respiratory Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hudson Respiratory Care, Inc. since 2007.

Recalls per year

2in 2026

2011: 12014: 22015: 1, 1 Class I2026 (partial year): 2
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hudson Respiratory Care, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hudson Respiratory Care, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)5decisions
  • BTMVentilator, Emergency, Manual (Resuscitator)2decisions
  • CAFNebulizer (Direct Patient Interface)2decisions
  • BYXTubing, Pressure And Accessories1decision
  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • CATCannula, Nasal, Oxygen1decision

Also: CCK (1), BSY (1), BZO (1).

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K930525Micro Mist (TM) NebulizerHudson Respiratory Care, Inc. · 19936cite it
  • K961914Bacteria/Viral FilterHudson Respiratory Care, Inc. · 19964cite it
  • K961150Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 19964cite it
  • K031383MODEL 780Hudson Respiratory Care, Inc. · 20032cite it
  • K944301Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380Hudson Respiratory Care, Inc. · 19942cite it
  • K923946Conchatherm IV Heated Molecular HumidifierHudson Respiratory Care, Inc. · 19942cite it

What has FDA decided for it lately?

  • K031383MODEL 780Hudson Respiratory Care, Inc. · 20033 recalls
  • K011134Oxygen Supply Tubing, Model 1115Hudson Respiratory Care, Inc. · 2001
  • K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by HrciHudson Respiratory Care, Inc. · 2001
  • K010402Smooth-Flo CircuitHudson Respiratory Care, Inc. · 2001
  • K001213Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60Hudson Respiratory Care, Inc. · 2000
  • K993355Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40, 780-41, 780-42, 780-43Hudson Respiratory Care, Inc. · 20001 recall
  • K994352Side Draft Neb-U-Mist Nebulizer, Model 41896Hudson Respiratory Care, Inc. · 2000
  • K964719Hudson Rci Lifesaver Single Patient Use Manual ResuscitatorHudson Respiratory Care, Inc. · 19971 Class I recall

All 15 as Hudson Respiratory Care, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K903083Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48…Jul 13, 2026Class II
  • K031383Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU…Jul 13, 2026Class II
  • K964719Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver…May 14, 2015Class I
  • K031383Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas…Jul 9, 2014Class II
  • K031383Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult…Apr 17, 2014Class II
  • K993355HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC…Jun 6, 2011

Other applicant names beginning “Hudson”

FDA records each applicant name separately; these may or may not be the same firm.

Hudson Oxygen Therapy Sales Co. 33Hudson Extrusions, Inc. 2Hudson Diagnostic Imaging, LLC 2Hudson Kendale Assoc., Inc. 1Hudson Rcj AB 1