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

Aspen Labs — Predicate Candidate Screening

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

302 daysmedian FDA review time

706 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K970493	HYFRECATOR 2000	Aspen Labs	1997-04-30	79	1
K925333	SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE	Aspen Labs	1994-09-27	706	0
K931215	HAND-TROL S	Aspen Labs	1994-03-28	383	0
K912046	SINGLE USE LEE ELECTRODE	Aspen Labs	1992-03-05	302	0
K905654	ELECTROSURGICAL UNIT WITH ACCESSORIES	Aspen Labs	1991-03-18	90	0
K904240	SINGLE USE LAPARSCOPIC ELECTRODE	Aspen Labs	1991-02-19	159	0

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