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

Ssi Medical Services, Inc. · Predicate Candidate Screening

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

140 daysmedian FDA review time

279 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K943385	CLINITRON ELEXIS	Ssi Medical Services, Inc.	1995-02-27	229	0
K942184	CLINITRON AT HOME AIR FLUIDED THERAPY	Ssi Medical Services, Inc.	1995-02-07	279	2
K914351	CLINITRON C-10	Ssi Medical Services, Inc.	1992-02-14	140	0
K890523	SUPERCAIR	Ssi Medical Services, Inc.	1989-02-10	8	0
K882161	ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM	Ssi Medical Services, Inc.	1988-07-12	50	0
K863047	FLEXICAIR	Ssi Medical Services, Inc.	1986-09-05	24	5

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