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

Pausch Corp. — Predicate Candidate Screening

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

27 daysmedian FDA review time

251 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K973864	COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO	Pausch Corp.	1998-06-17	251
K973834	CS2000 & CS2000 TOMO	Pausch Corp.	1998-04-30	204
K903395	UROMAT 2000	Pausch Corp.	1990-08-30	34
K870856	COSMOS	Pausch Corp.	1987-03-30	27
K790741	COMPACT SYSTEM	Pausch Corp.	1979-04-26	10
K790742	KS-78 VERTICAL WALL CASSETTE HOLDER	Pausch Corp.	1979-04-26	10
K790740	BS 66, UNIVERSAL BUCKY STAND	Pausch Corp.	1979-04-26	10
K790743	COORDINATUS, HORIZONTAL RADIOGRAPHOC	Pausch Corp.	1979-04-23	7

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