Respiratory Care, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Respiratory Care, Inc.” (first 1976, latest 1989), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 26 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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) | 8 | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 3 | 3 |
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 2 | 2 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 | 1 |
| BYH | Drain, Tee (Water Trap) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Plus 4 more product codes.
Review panels
- Anesthesiology (20)
- General Hospital (6)
Most recent Respiratory Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892230 | RCI VIRAL/BACTERIAL FILTER | CAH | 1989-08-28 | 146 |
| K884150 | MODIFIED CONCHATHERM III CONTROLLED HEATER | BTT | 1988-11-21 | 49 |
| K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL | BZE | 1988-06-21 | 70 |
| K864147 | AQUAVALVE | BYH | 1986-12-05 | 44 |
| K863955 | COLBY LEVEL ALARM | BTT | 1986-11-07 | 28 |
| K861555 | CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT | BZD | 1986-06-05 | 41 |
| K834151 | CONCHATHERM LHF HUMIDIFIER HEATER | BTT | 1984-01-13 | 43 |
| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER | BTT | 1983-12-16 | 30 |
| K832453 | SLIMB SINGLE LIMB BREATHING CIRCUIT | CAI | 1983-10-27 | 93 |
| K811524 | AQUACADE | LHC | 1981-07-01 | 33 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Respiratory Care, Inc..
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 Respiratory Care, Inc. (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.
- Respiratory Support Products, Inc. (27 510(k)s)
- Respiratory Motion, Inc. (5 510(k)s)
- Respiratory Delivery Systems, Inc. (2 510(k)s)
- Respiratory Marketing, Inc. (1 510(k)s)
- Respiratory Technologies, Incorporated (1 510(k)s)
- Respiratory Therapy (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Respiratory Care, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Respiratory Care, Inc.” (first 1976, latest 1989), across 14 product codes in 2 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 Respiratory Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respiratory Care, Inc. is 26 days.
Which FDA product codes appear under Respiratory Care, Inc.?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 8); CAF (Nebulizer (Direct Patient Interface), 3); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 3).
Next steps
- See all 26 Respiratory Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Respiratory Care, Inc.'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.