Atlas FDA

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

Top Surgical Manufacturers Co. · Predicate Candidate Screening

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

71 daysmedian FDA review time
98 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K844343TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPETop Surgical Manufacturers Co.1985-01-08600
K843415TOP HYPODERMIC SYRINGE LUER LOCKTop Surgical Manufacturers Co.1984-12-07980
K843313TOP DISPOSABLE SPINAL NEEDLETop Surgical Manufacturers Co.1984-09-19260
K843414TOP HYPODERMIC SYRINGE PISTONTop Surgical Manufacturers Co.1984-09-0770
K841119TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.1984-04-20360
K841025TOP DISPOSABLE INFUSION SETTop Surgical Manufacturers Co.1984-03-30180
K832624TOP VENULA I.V. CATHETER SETTop Surgical Manufacturers Co.1983-11-211090
K832625TOP THREE WAY STOPCOCKTop Surgical Manufacturers Co.1983-10-19760
K832622WINGED INFUSION SETTop Surgical Manufacturers Co.1983-10-14710
K832621TOP DISPOSABLE PLASTIC SYRINGESTop Surgical Manufacturers Co.1983-10-14710
K832623TOP DISPOS. INFUSION SET/HEMODIALYTop Surgical Manufacturers Co.1983-10-14710
K832626TOP STERILE DISPOS. HYPODERMIC NEEDLESTop Surgical Manufacturers Co.1983-10-14710

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