Burditt & Calkins-Siemens-Elema: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Burditt & Calkins-Siemens-Elema” (first 1976, latest 1984), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
| FAE | Prosthesis, Penile | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| HGY | Pump, Breast, Non-Powered | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
Review panels
- Cardiovascular (5)
- Anesthesiology (2)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Burditt & Calkins-Siemens-Elema 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833519 | PULSE GENERATOR MODEL 688 | DXY | 1984-01-30 | 111 |
| K833155 | RAYDEN MEDICAL MINI PULSE VOLUME RECORD | DSB | 1984-01-26 | 133 |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | DXY | 1983-05-27 | 114 |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | KRB | 1982-12-30 | 44 |
| K823591 | AMEDA HAND BREAST PUMP | HGY | 1982-12-28 | 22 |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | DTB | 1982-10-04 | 68 |
| K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 | BTY | 1982-07-26 | 47 |
| K803111 | ERECTAID | FAE | 1981-01-23 | 44 |
| K802607 | TERPERATUR SENSING DEVICE | FLL | 1980-11-19 | 29 |
| K760787 | LIBERATOR/STROLLER | BYJ | 1976-10-22 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Burditt & Calkins-Siemens-Elema.
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 Burditt & Calkins-Siemens-Elema (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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Burditt & Calkins-Siemens-Elema?
FDA lists 10 510(k) clearances under the applicant name “Burditt & Calkins-Siemens-Elema” (first 1976, latest 1984), across 9 product codes in 5 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 Burditt & Calkins-Siemens-Elema?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burditt & Calkins-Siemens-Elema is 46 days.
Which FDA product codes appear under Burditt & Calkins-Siemens-Elema?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 2); BTY (Calculator, Predicted Values, Pulmonary Function, 1); BYJ (Unit, Liquid-Oxygen, Portable, 1).
Next steps
- See all 10 Burditt & Calkins-Siemens-Elema clearances with predicates and recalls
- Run predicate analysis for product code DXY, Burditt & Calkins-Siemens-Elema'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.