Hudson Respiratory Care, Inc.: FDA clearances and approvals
Hudson Respiratory Care, Inc. has 15 FDA 510(k) clearances (first 1990, latest 2003), across 9 product codes in 2 review panels. Median 510(k) review time: 91 days. openFDA lists 1 product recall by a recalling firm named Hudson Respiratory Care, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 5 | 5 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (14)
- General Hospital (1)
Most recent Hudson Respiratory Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031383 | MODEL 780 | BTT | 2003-07-07 | 67 |
| K011134 | OXYGEN SUPPLY TUBING, MODEL 1115 | BYX | 2001-06-13 | 61 |
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | CAT | 2001-06-13 | 61 |
| K010402 | SMOOTH-FLO CIRCUIT | BTT | 2001-03-14 | 30 |
| K001213 | CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 | BTT | 2000-11-03 | 203 |
| K993355 | HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 | BTT | 2000-05-24 | 231 |
| K994352 | SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 | CAF | 2000-03-22 | 90 |
| K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR | BTM | 1997-02-21 | 88 |
| K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | CCK | 1996-09-10 | 172 |
| K961914 | BACTERIA/VIRAL FILTER | CAH | 1996-08-14 | 89 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-04-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Hudson Respiratory Care, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Hudson Respiratory Care, Inc. have?
Hudson Respiratory Care, Inc. has 15 FDA 510(k) clearances (first 1990, latest 2003), across 9 product codes in 2 review panels.
How long does FDA take to clear Hudson Respiratory Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hudson Respiratory Care, Inc.'s cleared 510(k)s is 91 days.
What devices does Hudson Respiratory Care, Inc. make?
Its most frequent FDA product codes are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 5); BTM (Ventilator, Emergency, Manual (Resuscitator), 2); CAF (Nebulizer (Direct Patient Interface), 2).
Has Hudson Respiratory Care, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Hudson Respiratory Care, Inc; the most recent began 2004-04-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Hudson Respiratory Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Hudson Respiratory Care, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.