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

Hyperion, Inc. — Predicate Candidate Screening

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

94 daysmedian FDA review time

360 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K022800	VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM	Hyperion, Inc.	2002-11-25	94
K013213	HYPERION VISIQUANT ANA TEST KIT	Hyperion, Inc.	2002-06-04	251
K935983	MICROREADER 4	Hyperion, Inc.	1994-12-09	360
K913809	HY-PREP SYSTEM	Hyperion, Inc.	1992-01-15	142
K873138	MICRO-READER II	Hyperion, Inc.	1987-09-14	35
K864060	MICRO-READER	Hyperion, Inc.	1986-11-28	39
K855149	COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER	Hyperion, Inc.	1986-02-11	47
K834071	LYMPHANGIOGRAPHY SET SPECIAL 30G	Hyperion, Inc.	1984-01-25	61

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