Company ยท US
Hudson Respiratory Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2003. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 6 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| BYX | Tubing, Pressure And Accessories | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2003 | K031383 | MODEL 780 Hudson Respiratory Care, Inc. | BTT |
| Jun 13, 2001 | K011134 | OXYGEN SUPPLY TUBING, MODEL 1115 Hudson Respiratory Care, Inc. | BYX |
| Jun 13, 2001 | K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI Hudson Respiratory Care, Inc. | CAT |
| Mar 14, 2001 | K010402 | SMOOTH-FLO CIRCUIT Hudson Respiratory Care, Inc. | BTT |
| Nov 3, 2000 | K001213 | CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 Hudson Respiratory Care, Inc. | BTT |
| May 24, 2000 | K993355 | HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 Hudson Respiratory Care, Inc. | BTT |
| Mar 22, 2000 | K994352 | SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 Hudson Respiratory Care, Inc. | CAF |
| Feb 21, 1997 | K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR Hudson Respiratory Care, Inc. | BTM |
| Sep 10, 1996 | K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA Hudson Respiratory Care, Inc. | CCK |
| Aug 14, 1996 | K961914 | BACTERIA/VIRAL FILTER Hudson Respiratory Care, Inc. | CAH |
| Mar 12, 1996 | K955645 | CATH-GUIDE Hudson Respiratory Care, Inc. | BSY |
| Dec 21, 1994 | K944301 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 Hudson Respiratory Care, Inc. | BTM |
| Oct 18, 1994 | K923946 | CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER Hudson Respiratory Care, Inc. | BTT |
| Sep 29, 1993 | K930525 | MICRO MIST(TM) NEBULIZER Hudson Respiratory Care, Inc. | CAF |
| Dec 27, 1990 | K903083 | NEONATAL VENTILATOR CIRCUIT Hudson Respiratory Care, Inc. | BZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Hudson Respiratory Care Inc Concha IV Plus Heated Humidifier Terminated |
BTT | None listed |