Siemens Life Support Systems: FDA clearances and approvals
Siemens Life Support Systems has 6 FDA 510(k) clearances (first 1989, latest 1991), across 4 product codes in 1 review panel. Median 510(k) review time: 116 days.
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 | 3 | 3 |
| BRY | Cabinet, Table And Tray, Anesthesia | 1 | 1 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Siemens Life Support Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902859 | SERVO VENTILATOR 300 | CBK | 1991-04-26 | 301 |
| K903991 | PCM ANESTHESIA | BSZ | 1991-02-25 | 180 |
| K901474 | ANESTHESIA WORKSTATION | BRY | 1990-04-10 | 14 |
| K893786 | SERVO ANESTHESIA CIRCLE 985 | CBK | 1989-09-22 | 123 |
| K890932 | CAV 3.0C SOFTWARE PROGRAM | BZK | 1989-06-12 | 108 |
| K890921 | DATA EXCHANGE SYSTEM, MODEL 24 | CBK | 1989-06-08 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Life Support Systems.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Siemens Life Support Systems have?
Siemens Life Support Systems has 6 FDA 510(k) clearances (first 1989, latest 1991), across 4 product codes in 1 review panel.
How long does FDA take to clear Siemens Life Support Systems's 510(k)s?
The median time from FDA receipt to decision across Siemens Life Support Systems's cleared 510(k)s is 116 days.
What devices does Siemens Life Support Systems make?
Its most frequent FDA product codes are CBK (Ventilator, Continuous, Facility Use, 3); BRY (Cabinet, Table And Tray, Anesthesia, 1); BSZ (Gas-Machine, Anesthesia, 1).
Has Siemens Life Support Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens Life Support Systems. Related entities may recall under other names.
Next steps
- See all 6 Siemens Life Support Systems clearances with predicates and recalls
- Run predicate analysis for product code CBK, Siemens Life Support Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.