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

JEH — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

218 daysmedian FDA review time

393 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K240706	PowerCube+ Series (PowerCube Body+); PowerCube+ Series (Powe	Ganshorn Medizin Electronic GmbH	2024-12-09	270
K223818	Model 9160 VitaloQUB	Vitalograph Ireland, Ltd.	2023-05-25	155
K072061	MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY	Viasys Healthcare GmbH	2008-04-22	270
K022636	BODY BOX 5500	Morgan Scientific, Inc.	2003-01-13	158
K960840	C.E. VASCULAR MACHINE	C.E. Diagnosis, Inc.	1997-03-28	393
K953642	AP-18	Jeneric/Pentron, Inc.	1995-12-12	130
K951901	MASTERSCREEN PFT BODY	Erich Jaeger GmbH & Co. KG	1995-07-31	98
K936108	MASTERSCREEN BODY	Erich Jaeger GmbH & Co. KG	1995-02-03	403
K932812	EC 5R PLETHYSMOGRAPH	D. E. Hokanson, Inc.	1994-01-13	218
K925040	TELEPULSE	Biometrix , Ltd.	1993-08-23	322
K851197	CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH	Cybermedic, Inc.	1985-07-08	104

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