Elema-Schonander, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Elema-Schonander, Inc.” (first 1977, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 | 5 | 5 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 4 | 4 |
| KPX | Changer, Radiographic Film/Cassette | 2 | 2 |
Review panels
- Radiology (6)
- Cardiovascular (5)
Most recent Elema-Schonander, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934944 | MPQ-42 | IZP | 1993-12-15 | 58 |
| K904103 | SEP 90 | IZP | 1990-11-20 | 75 |
| K903576 | PUCK 90M | KPX | 1990-09-04 | 27 |
| K842911 | PUCK U & UD CUTFILM CHANGERS | KPX | 1984-08-21 | 29 |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | IZP | 1984-08-21 | 28 |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | IZP | 1984-02-21 | 22 |
| K790792 | PULSE GENERATOR MODEL 637 | DXY | 1979-10-12 | 171 |
| K790670 | PULSE GENERATOR MODEL 629 | DXY | 1979-06-27 | 82 |
| K781178 | PULSE GENERATOR MODEL 208 | DXY | 1978-09-07 | 59 |
| K770005 | PACEMAKER 208S | DXY | 1977-02-24 | 52 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elema-Schonander, Inc..
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 Elema-Schonander, Inc. (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 Elema-Schonander, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Elema-Schonander, Inc.” (first 1977, latest 1993), across 3 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 Elema-Schonander, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elema-Schonander, Inc. is 52 days.
Which FDA product codes appear under Elema-Schonander, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 5); IZP (Programmer, Changer, Film/Cassette, Radiographic, 4); KPX (Changer, Radiographic Film/Cassette, 2).
Next steps
- See all 11 Elema-Schonander, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Elema-Schonander, Inc.'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.