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

DXS · Predicate Candidate Screening

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

49 daysmedian FDA review time

91 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K113235	PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NO	Medtronic, Inc.	2011-12-02	30	1
K944764	VTI DISPOSABLE PRESSURE DISPLAY SET	Vascular Technology Incorporated	1994-12-27	91	0
K912045	TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST	Lifestream Int'L, Inc.	1991-10-31	176	0
K900797	STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR	Shiley, Inc.	1990-05-10	79	0
K873802	PRESSURE BARRIER KIT CAT. NO. PBK-3	American Omni Medical, Inc.	1987-11-06	49	0
K862836	STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE	Shiley, Inc.	1986-09-12	49	0
K852232	PRESSURE DISPLAY BOX #60000/TUBING SET #61000	Dlp, Inc.	1985-08-09	79	4
K842194	PRESSURE MONITOR	Norton Texas Medical Products	1984-08-27	84	0
K831750	PM-3	Delta Medical Industries	1983-07-26	55	0
K822822	GAMBRO PRESSURE MONITOR PRM 10	Gambro, Inc.	1982-10-18	28	0
K820912	PMS-2 PRESSURE MONITOR SEPARATOR	Delta Medical Industries	1982-05-18	47	0
K781890	CHAMBER, MC-1 DISPOSABLE PRESSURE	Delta Medical Industries	1978-12-04	28	0
K771764	CORONARY PRESSURE PERFUSION PUMP	3M Health Care, Sarns	1977-09-30	11	0

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