Hudson Oxygen Therapy Sales Co.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Hudson Oxygen Therapy Sales Co.” (first 1976, latest 1990), across 22 product codes in 4 review panels. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Teleflex, based on public ownership records.
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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| CAW | Generator, Oxygen, Portable | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BYI | Percussor, Powered-Electric | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| CBP | Valve, Non-Rebreathing | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
Plus 12 more product codes.
Review panels
- Anesthesiology (27)
- General Hospital (4)
- Cardiovascular (1)
- Neurology (1)
Most recent Hudson Oxygen Therapy Sales Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902062 | PEEP VALVE | BYE | 1990-09-04 | 119 |
| K900783 | MDI ADAPTOR | CAF | 1990-07-18 | 148 |
| K900470 | IN-THE NEBULIZER | CAF | 1990-05-18 | 107 |
| K895589 | MANUAL RESUSCITATOR | BTM | 1990-03-30 | 196 |
| K896136 | INFANT C.P.A.P. MONITOR | CAP | 1990-01-09 | 78 |
| K895747 | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR | CAP | 1989-10-27 | 31 |
| K895231 | CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER | CAF | 1989-10-27 | 66 |
| K890035 | BACTERIA FILTER | CAH | 1989-05-05 | 121 |
| K870895 | NO. 1552, VALVED VENTI-COMP | CBP | 1987-05-04 | 60 |
| K871157 | C.P.A.P. NASAL CANNULA | BZD | 1987-04-21 | 28 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hudson Oxygen Therapy Sales Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hudson Oxygen Therapy Sales Co. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hudson Respiratory Care, Inc. (15 510(k)s)
- Hudson Diagnostic Imaging, LLC (2 510(k)s)
- Hudson Extrusions, Inc. (2 510(k)s)
- Hudson Kendale Assoc., Inc. (1 510(k)s)
- Hudson Rcj AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hudson Oxygen Therapy Sales Co.?
FDA lists 33 510(k) clearances under the applicant name “Hudson Oxygen Therapy Sales Co.” (first 1976, latest 1990), across 22 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hudson Oxygen Therapy Sales Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hudson Oxygen Therapy Sales Co. is 34 days.
Which FDA product codes appear under Hudson Oxygen Therapy Sales Co.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 4); CAW (Generator, Oxygen, Portable, 3); BTM (Ventilator, Emergency, Manual (Resuscitator), 2).
Next steps
- See all 33 Hudson Oxygen Therapy Sales Co. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Hudson Oxygen Therapy Sales Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.