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

Endotherapeutics — Predicate Candidate Screening

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

54 daysmedian FDA review time

98 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K870855	UROSCAN	Endotherapeutics	1987-06-09	98
K860192	ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE	Endotherapeutics	1986-03-17	54
K860102	MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE	Endotherapeutics	1986-02-12	33
K860103	MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE	Endotherapeutics	1986-02-12	33
K852031	ENDOPORT 5MM	Endotherapeutics	1985-08-13	96
K844619	ENDONEEDLE	Endotherapeutics	1985-01-09	43
K841716	ENDOPORT EROCAR	Endotherapeutics	1984-06-28	64

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