Acutronic Medical Systems AG: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Acutronic Medical Systems AG” (first 1986, latest 2002), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 310 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 | 6 | 6 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (11)
Most recent Acutronic Medical Systems AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012691 | MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES | CBK | 2002-12-20 | 493 |
| K012693 | MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES | CBK | 2002-08-01 | 352 |
| K936009 | AMS 3000M | CAP | 1995-05-03 | 503 |
| K900745 | VS-200S JET VENTILATOR | CBK | 1991-04-29 | 437 |
| K900744 | AMS 3000 PORTABLE JET VENTILATOR | CBK | 1991-04-29 | 437 |
| K883865 | EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 | CBK | 1989-06-08 | 268 |
| K863155 | UNIVERSAL JET VENTILATOR MODEL AMS-1000 | CBK | 1987-09-28 | 409 |
| K863154 | HEATED JET HUMIDIFIER MODEL AMS-1020 | BTT | 1987-01-12 | 150 |
| K862436 | TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) | BTO | 1986-11-03 | 130 |
| K862435 | DOUBLE LUMEN E T ADAPTOR | BZA | 1986-10-22 | 118 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acutronic Medical Systems AG.
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 Acutronic Medical Systems AG?
FDA lists 12 510(k) clearances under the applicant name “Acutronic Medical Systems AG” (first 1986, latest 2002), across 6 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 Acutronic Medical Systems AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acutronic Medical Systems AG is 310 days.
Which FDA product codes appear under Acutronic Medical Systems AG?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 6); BZA (Connector, Airway (Extension), 2); BTO (Tube, Tracheostomy (W/Wo Connector), 1).
Next steps
- See all 12 Acutronic Medical Systems AG clearances with predicates and recalls
- Run predicate analysis for product code CBK, Acutronic Medical Systems AG'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.