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

Support Systems Intl. — Predicate Candidate Screening

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

68 daysmedian FDA review time

316 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K941610	CLENSICAIR LOW AIRLOSS HYDROTHERAPY	Support Systems Intl.	1995-02-10	316	0
K940662	I-5000	Support Systems Intl.	1994-06-15	117	0
K922973	RESTCUE CC	Support Systems Intl.	1992-07-30	38	0
K920382	FLEXICAIR LOW AIRLOSS THERAPY UNIT	Support Systems Intl.	1992-04-07	68	0
K920112	CLINITRON C-II	Support Systems Intl.	1992-01-24	14	2

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