Siemens Elema AB: FDA clearances and approvals
Siemens Elema AB has 63 FDA 510(k) clearances (first 1978, latest 2003), across 27 product codes in 5 review panels. Median 510(k) review time: 76 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 | 15 | 15 |
| DXY | Implantable Pacemaker Pulse-Generator | 15 | 15 |
| DTB | Permanent Pacemaker Electrode | 3 | 3 |
| BTI | Compressor, Air, Portable | 2 | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 2 | 2 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| DPS | Electrocardiograph | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
Plus 17 more product codes.
Review panels
- Anesthesiology (34)
- Cardiovascular (25)
- General Hospital (1)
- Radiology (1)
- Clinical Toxicology (1)
Most recent Siemens Elema AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | BTI | 2003-09-05 | 333 |
| K010923 | KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E | MHX | 2002-01-23 | 302 |
| K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E | CBK | 2001-12-18 | 266 |
| K002137 | CATHCOR DESKTOP | DQK | 2000-10-05 | 83 |
| K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM | BSZ | 2000-05-26 | 30 |
| K970839 | SERVO VENTILATOR 300A | CBK | 1997-10-14 | 221 |
| K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 | CBK | 1996-10-25 | 283 |
| K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE | CBK | 1996-10-25 | 297 |
| K872278 | SIEMENS O2-AIR MIXER 965 | BZR | 1987-09-03 | 80 |
| K871354 | SERVO VENTILATOR 900 C/D | CBK | 1987-07-21 | 106 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Elema AB.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Siemens Elema AB's product codes (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Siemens Elema AB have?
Siemens Elema AB has 63 FDA 510(k) clearances (first 1978, latest 2003), across 27 product codes in 5 review panels.
How long does FDA take to clear Siemens Elema AB's 510(k)s?
The median time from FDA receipt to decision across Siemens Elema AB's cleared 510(k)s is 76 days.
What devices does Siemens Elema AB make?
Its most frequent FDA product codes are CBK (Ventilator, Continuous, Facility Use, 15); DXY (Implantable Pacemaker Pulse-Generator, 15); DTB (Permanent Pacemaker Electrode, 3).
Has Siemens Elema AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens Elema AB. Related entities may recall under other names.
Next steps
- See all 63 Siemens Elema AB clearances with predicates and recalls
- Run predicate analysis for product code CBK, Siemens Elema AB'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.