Artec Environmental Monitoring Division: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Artec Environmental Monitoring Division” (first 1983, latest 1990), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| KNN | Components, Wheelchair | 1 | 1 |
Review panels
- Anesthesiology (6)
- Physical Medicine (1)
Most recent Artec Environmental Monitoring Division 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900839 | THE CAROLINA ROCKER | KNN | 1990-04-18 | 55 |
| K896886 | ARTEC RESPOND PULMONARY RESUSCITATOR | BTM | 1990-02-06 | 60 |
| K873043 | MOUTH TO FACE RESUSCITATOR | BTM | 1987-09-28 | 55 |
| K863910 | RAINCOAT | BZO | 1986-10-20 | 12 |
| K854573 | ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE | CAI | 1986-01-03 | 50 |
| K832512 | AIRWAY MASKS | CAE | 1984-01-17 | 174 |
| K830056 | ARTEC TWIST VALVE | BTC | 1983-03-09 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Artec Environmental Monitoring Division.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Artec Environmental Monitoring Division?
FDA lists 7 510(k) clearances under the applicant name “Artec Environmental Monitoring Division” (first 1983, latest 1990), across 6 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 Artec Environmental Monitoring Division?
The median time from FDA receipt to decision across 510(k)s cleared under the name Artec Environmental Monitoring Division is 55 days.
Which FDA product codes appear under Artec Environmental Monitoring Division?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 2); BTC (Bag, Reservoir, 1); BZO (Set, Tubing And Support, Ventilator (W Harness), 1).
Next steps
- See all 7 Artec Environmental Monitoring Division clearances with predicates and recalls
- Run predicate analysis for product code BTM, Artec Environmental Monitoring Division'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.