Sensor Medics Corp.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Sensor Medics Corp.” (first 1984, latest 2004), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 169 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 7 | 7 |
| BZG | Spirometer, Diagnostic | 5 | 5 |
| DQA | Oximeter | 3 | 3 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 | 2 |
| BZC | Calculator, Pulmonary Function Data | 2 | 2 |
| CBP | Valve, Non-Rebreathing | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (22)
- Neurology (2)
- Dental (1)
- General Hospital (1)
Most recent Sensor Medics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032516 | HIOX80 AEROSOL ADAPTER | CAF | 2004-03-04 | 203 |
| K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | BZD | 2004-02-13 | 253 |
| K031883 | LYRA NASAL MASK | BZD | 2003-08-25 | 68 |
| K030943 | MODIFICATION TO HIOX | CBP | 2003-04-22 | 27 |
| K022192 | PEGASUS NASAL CPAP SYSTEM | BZD | 2003-01-24 | 203 |
| K020665 | HI-OX | CBP | 2002-07-30 | 151 |
| K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | OLV | 2001-08-02 | 30 |
| K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | BZD | 2001-07-24 | 25 |
| K991972 | INFANT FLOW SYSTEM | BZD | 1999-08-13 | 63 |
| K984254 | INFANT FLOW NCPAP MASKS | BZD | 1999-02-24 | 89 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sensor Medics Corp..
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 Sensor Medics Corp. (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.
- Sensor Medical Technology, LLC (3 510(k)s)
- Sensor Dynamics, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sensor Medics Corp.?
FDA lists 26 510(k) clearances under the applicant name “Sensor Medics Corp.” (first 1984, latest 2004), across 11 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 Sensor Medics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sensor Medics Corp. is 169 days.
Which FDA product codes appear under Sensor Medics Corp.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 7); BZG (Spirometer, Diagnostic, 5); DQA (Oximeter, 3).
Next steps
- See all 26 Sensor Medics Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Sensor Medics Corp.'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.