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

Baltimore Therapeutic Equipment Co. · Predicate Candidate Screening

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

165 daysmedian FDA review time

619 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K955106	BTE CPM-20	Baltimore Therapeutic Equipment Co.	1995-12-29	51	0
K955105	BTE CPM-10	Baltimore Therapeutic Equipment Co.	1995-12-29	51	0
K925225	THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK	Baltimore Therapeutic Equipment Co.	1994-06-27	619	0
K933611	THE BTE WS30	Baltimore Therapeutic Equipment Co.	1994-06-20	336	1
K924414	THE BTE DYNAMIC LIFT	Baltimore Therapeutic Equipment Co.	1993-02-12	165	0
K895881	MOTIONSPECT	Baltimore Therapeutic Equipment Co.	1990-04-10	187	0
K800007	WORK SIMULATOR	Baltimore Therapeutic Equipment Co.	1980-01-21	18	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