Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Nor-Am Patient Care Products, Inc. · Predicate Candidate Screening

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

175 daysmedian FDA review time

255 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K900647	SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC	Nor-Am Patient Care Products, Inc.	1990-10-22	255
K844387	ESCOTEK-EST 221 VACUUM UNIT	Nor-Am Patient Care Products, Inc.	1985-05-07	175
K844388	ESCOTEK EST 220 INTERFERENCE THERAPY UNIT	Nor-Am Patient Care Products, Inc.	1985-05-07	175
K844389	ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI	Nor-Am Patient Care Products, Inc.	1985-05-07	175
K844390	ESCOTEK-EST 204 MULTI STIM	Nor-Am Patient Care Products, Inc.	1985-05-07	175
K844385	ESCOTEK EST TRAC 401	Nor-Am Patient Care Products, Inc.	1985-05-01	169
K844386	ESCOTEK-EST 301A ULTRA-SONIC UNIT	Nor-Am Patient Care Products, Inc.	1985-05-01	169

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