Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sears, Roebuck & Co. — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time
59 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K810635ELECTRODE BLOOD PRESSURE MONITORSears, Roebuck & Co.1981-05-08590
K800778DIGITAL ELECTRONIC B.P. MONITOR 2155Sears, Roebuck & Co.1980-04-29210
K800072DIGITAL ELECTRONIC EXERCISER/PULSE MTR.Sears, Roebuck & Co.1980-01-28140
K781701BLOOD PRESSURE, DIGITAL MODEL #2153Sears, Roebuck & Co.1978-12-04550
K780986DIGITAL BLOOD PRESSURE MONITORSears, Roebuck & Co.1978-07-18340
K771666SPHYGMOMANOMETER #1235Sears, Roebuck & Co.1977-09-30300

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda