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

JFC — Predicate Candidate Screening

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

85 daysmedian FDA review time

154 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K924705	FORCE SENSING ARRAY	Force Sensing Systems	1993-05-12	237
K925258	DYNAMIC PRESSURE MONITOR 2000M AND 2000C	Pin Dot Products, Inc.	1993-03-09	141
K925052	QA PRESSURE MEASUREMENT SYSTEM	Gabel Medical Instruments, Ltd.	1993-03-09	154
K915278	CDG GAIT ANALYSES SYSTEM	Wrm Computers	1992-04-07	134
K914776	OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR	Talley Group, Ltd.	1991-12-19	57
K913510	MECHANICAL SHAPE SENSOR	Pin Dot Products, Inc.	1991-09-23	47
K881284	COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE	Nathaniel Gould Diagnostics, Inc.	1988-07-21	118
K882139	2P-QDA FOOT PRESSURE SYSTEMS REAL TIME	Human Performance Technologies, Inc.	1988-06-22	30
K861260	PEDABAROGRAPH	Biokinetics, Inc.	1986-05-02	29
K831800	TEXAS INTERFACE PRESSURE EVALUATOR-TIPE	Tee-Kay Applied Technology	1983-08-16	85
K823681	MODEL ICPM & ACCESSORIES	Electromedics, Inc.	1983-02-23	78

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