Bourns Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Bourns Medical Systems, Inc.” (first 1978, latest 1980), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 5 | 5 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (9)
Most recent Bourns Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802118 | BEAR 2 ADULT VOL. VENTILATOR | CBK | 1980-10-03 | 29 |
| K802051 | NEWBOURNS INFANT VENTILATOR | CBK | 1980-10-03 | 39 |
| K801697 | MODEL BP-200 INFANT PRESSURE VENTILATOR | CBK | 1980-08-07 | 15 |
| K791186 | MODEL BP-2000 TIME-CYCLED VENTILATOR | CBK | 1979-07-06 | 11 |
| K790199 | VENTILATOR MODEL BV-300 INFANT | CBK | 1979-04-13 | 77 |
| K781760 | HUMIDIFIERS, MODEL:LS-420 AND LS-460 | BTT | 1978-12-20 | 65 |
| K781485 | PATIENT CIRCUIT MANIFOLD | CAF | 1978-10-16 | 49 |
| K781515 | MODEL LS-80 ADULT VENTILATION MONITOR | BZQ | 1978-10-02 | 32 |
| K781428 | FLEXTUBES:9, 20, 26 | BYX | 1978-09-11 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Bourns Medical Systems, 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 Bourns Medical Systems, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Bourns Medical Systems, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Bourns Medical Systems, Inc.” (first 1978, latest 1980), across 5 product codes 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 Bourns Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bourns Medical Systems, Inc. is 32 days.
Which FDA product codes appear under Bourns Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 5); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1); BYX (Tubing, Pressure And Accessories, 1).
Next steps
- See all 9 Bourns Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Bourns Medical Systems, 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.