Sears, Roebuck & Co.: FDA clearances and approvals
Sears, Roebuck & Co. has 6 FDA 510(k) clearances (first 1977, latest 1981), across 4 product codes in 2 review panels. Median 510(k) review time: 32 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
Review panels
- Cardiovascular (5)
- Physical Medicine (1)
Most recent Sears, Roebuck & Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810635 | ELECTRODE BLOOD PRESSURE MONITOR | DSK | 1981-05-08 | 59 |
| K800778 | DIGITAL ELECTRONIC B.P. MONITOR 2155 | DXN | 1980-04-29 | 21 |
| K800072 | DIGITAL ELECTRONIC EXERCISER/PULSE MTR. | ISD | 1980-01-28 | 14 |
| K781701 | BLOOD PRESSURE, DIGITAL MODEL #2153 | DSK | 1978-12-04 | 55 |
| K780986 | DIGITAL BLOOD PRESSURE MONITOR | DXN | 1978-07-18 | 34 |
| K771666 | SPHYGMOMANOMETER #1235 | DXG | 1977-09-30 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Sears, Roebuck & Co..
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 Sears, Roebuck & Co. have?
Sears, Roebuck & Co. has 6 FDA 510(k) clearances (first 1977, latest 1981), across 4 product codes in 2 review panels.
How long does FDA take to clear Sears, Roebuck & Co.'s 510(k)s?
The median time from FDA receipt to decision across Sears, Roebuck & Co.'s cleared 510(k)s is 32 days.
What devices does Sears, Roebuck & Co. make?
Its most frequent FDA product codes are DSK (Computer, Blood-Pressure, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 1).
Has Sears, Roebuck & Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sears, Roebuck & Co. Related entities may recall under other names.
Next steps
- See all 6 Sears, Roebuck & Co. clearances with predicates and recalls
- Run predicate analysis for product code DSK, Sears, Roebuck & Co.'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.