Hudson Respiratory Care, Inc.
Temecula, CA, US
Hudson Respiratory Care, Inc. appears in FDA device records in Temecula, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Hudson Respiratory Care, Inc. between 1990 and 2003. The busiest year on record is 1996, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1996 | 3 |
| 1997 | 1 |
| 2000 | 3 |
| 2001 | 3 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K031383 | MODEL 780 | BTT | Substantially Equivalent | |
| K011134 | OXYGEN SUPPLY TUBING, MODEL 1115 | BYX | Substantially Equivalent | |
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | CAT | Substantially Equivalent | |
| K010402 | SMOOTH-FLO CIRCUIT | BTT | Substantially Equivalent | |
| K001213 | CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 | BTT | Substantially Equivalent | |
| K993355 | HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 | BTT | Substantially Equivalent | |
| K994352 | SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 | CAF | Substantially Equivalent | |
| K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | |
| K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | CCK | Substantially Equivalent | |
| K961914 | BACTERIA/VIRAL FILTER | CAH | Substantially Equivalent | |
| K955645 | CATH-GUIDE | BSY | Substantially Equivalent | |
| K944301 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 | BTM | Substantially Equivalent | |
| K923946 | CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER | BTT | Substantially Equivalent | |
| K930525 | MICRO MIST(TM) NEBULIZER | CAF | Substantially Equivalent | |
| K903083 | NEONATAL VENTILATOR CIRCUIT | BZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CATCannula, Nasal, Oxygen
- BSYCatheters, Suction, Tracheobronchial
- CAHFilter, Bacterial, Breathing-Circuit
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CAFNebulizer (Direct Patient Interface)
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BYXTubing, Pressure And Accessories
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0929-04 | Concha IV Plus Heated Humidifier | Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain