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

Ketronic, Inc. — Predicate Candidate Screening

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

103 daysmedian FDA review time

103 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K850869	MFE COUCH ERGOMETER	Ketronic, Inc.	1985-06-12	103
K850870	MEDIFETTE ERGOMETER	Ketronic, Inc.	1985-06-12	103
K850868	MFE CARDIAC STRESS SYSTEM	Ketronic, Inc.	1985-06-12	103
K850873	HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL	Ketronic, Inc.	1985-06-12	103
K850877	MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR	Ketronic, Inc.	1985-06-12	103
K850872	PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI	Ketronic, Inc.	1985-06-06	97
K850871	TREDBAND TYPE I, IT, II & III - TREADMILLS	Ketronic, Inc.	1985-06-05	96
K850876	LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR	Ketronic, Inc.	1985-05-16	76
K850875	ACTION-WHEELS & PLAY WHEELS	Ketronic, Inc.	1985-05-16	76
K843288	KETRONIC MEDAX - N	Ketronic, Inc.	1984-11-08	79

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