Atlas FDA

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

Fraser Sweatman, Inc. — Predicate Candidate Screening

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

21 daysmedian FDA review time
39 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K771299EMERGENCY OXYGEN RESUSCITATORFraser Sweatman, Inc.1977-08-04210
K770911MEDISHIELD JORDON LIFTING FRAMEFraser Sweatman, Inc.1977-06-27390
K770910MEDISHIELD CERVICAL COLLARFraser Sweatman, Inc.1977-05-2560
K761140FRASER SWEATMAN'S DOUBLE MASKFraser Sweatman, Inc.1976-12-09130
K760766PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXERFraser Sweatman, Inc.1976-10-0840
K760076ABSORBER, ANESTHESIA CIRCLE SYS, CO2Fraser Sweatman, Inc.1976-07-16280

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