Atlas FDA

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

Scientific Sales Intl., Inc. — Predicate Candidate Screening

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

38 daysmedian FDA review time
184 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., Inc.1995-08-25180
K940799FLEXGUIDEScientific Sales Intl., Inc.1994-08-181770
K860996SANASSAY IC TESTScientific Sales Intl., Inc.1987-03-303840
K862087SANTEST 1APScientific Sales Intl., Inc.1986-12-031840
K861336IAP PLATE TESTScientific Sales Intl., Inc.1986-04-25160
K853284MYREADER 7Scientific Sales Intl., Inc.1985-10-04600
K853285MYWASHER 5Scientific Sales Intl., Inc.1985-10-04600
K853380SPR 2 AUTODILUTERScientific Sales Intl., Inc.1985-09-12310
K853379PLATE INCUBATORScientific Sales Intl., Inc.1985-09-03220
K833022AIR UTERINE DISPLACER-AUD 120Scientific Sales Intl., Inc.1983-10-14380
K802416SALEM/RESCE INTUBATION GUIDEScientific Sales Intl., Inc.1980-10-23170

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