Respiratory Support Products, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Respiratory Support Products, Inc.” (first 1979, latest 1999), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 10 | 10 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 | 1 |
| ESE | Larynx, Artificial (Battery-Powered) | 1 | 1 |
| EZK | Catheter, Retention Type | 1 | 1 |
Plus 3 more product codes.
Review panels
- Anesthesiology (12)
- General Hospital (10)
- Gastroenterology and Urology (2)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
Most recent Respiratory Support Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983862 | CLOUD 1 HUMIDIFICATION SYSTEM | BTT | 1999-05-24 | 203 |
| K921190 | ADAP-TEMP TEMPERATURE SENSOR ADAPTER | FLL | 1993-03-09 | 365 |
| K920469 | MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE | FLL | 1992-09-11 | 228 |
| K921510 | GAS SAMPLING KIT MODIFICATION | BZO | 1992-06-11 | 90 |
| K913082 | BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D | FLL | 1991-12-11 | 202 |
| K913083 | BI-TEMP TEMPERATURE MONITOR TM-201D | FLL | 1991-10-17 | 147 |
| K912280 | BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D | FLL | 1991-10-17 | 147 |
| K903816 | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR | EZK | 1990-10-31 | 72 |
| K874694 | ADAP-TEMP, MODEL: AT-100 | FLL | 1988-03-01 | 109 |
| K873472 | MEMBRANE HUMIDIFIER | BTT | 1988-01-19 | 144 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Respiratory Support Products, 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.
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 Care, Inc. (26 510(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 Support Products, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Respiratory Support Products, Inc.” (first 1979, latest 1999), across 13 product codes in 5 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 Support Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respiratory Support Products, Inc. is 68 days.
Which FDA product codes appear under Respiratory Support Products, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 10); BTR (Tube, Tracheal (W/Wo Connector), 2); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2).
Next steps
- See all 27 Respiratory Support Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Respiratory Support Products, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.