Respiratory Motion, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Respiratory Motion, Inc.” (first 2012, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 168 days. Since 2017 the median was 168 days, against 190 days for all cleared 510(k)s in the same product codes. 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 | 1 | 259 |
| 2013 | 1 | 125 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 281 |
| 2018 | 1 | 168 |
| 2019 | 1 | 88 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Respiratory Motion, Inc. took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Respiratory Motion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192595 | ExSpiron 2Xi | BZK | 2019-12-17 | 88 |
| K173181 | ExSpiron 1Xi | BZK | 2018-03-16 | 168 |
| K162131 | ExSpiron 1Xi | BZK | 2017-05-09 | 281 |
| K130170 | EXSPIRON 1XI | BZK | 2013-05-29 | 125 |
| K120087 | EXSPIRON | BZK | 2012-09-26 | 259 |
Recalls
openFDA lists no recalls under a recalling firm named Respiratory Motion, 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.
Device clinical trials
An industry sponsor named Respiratory Motion, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02690298: Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration (Completed, started 2015-09-01)
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 Care, Inc. (26 510(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 Motion, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Respiratory Motion, Inc.” (first 2012, latest 2019), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Respiratory Motion, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respiratory Motion, Inc. is 168 days. Since 2017: 168 days, versus 190 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Respiratory Motion, Inc.?
The most frequent FDA product codes under this applicant name are BZK (Spirometer, Monitoring (W/Wo Alarm), 5).
Next steps
- See all 5 Respiratory Motion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZK, Respiratory Motion, 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.