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

South Mountain Medical — Predicate Candidate Screening

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

32 daysmedian FDA review time

46 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K853742	GAUZE SPONGE	South Mountain Medical	1985-10-08	32
K852945	HUCK TOWEL	South Mountain Medical	1985-07-29	18
K851276	ACTION PAC	South Mountain Medical	1985-05-15	44
K831806	SUTURE KITS STERILIZED W/GAMA RADIATION	South Mountain Medical	1983-06-29	26
K823485	SURE SNIP	South Mountain Medical	1982-12-03	10
K812992	SURGICAL MASK	South Mountain Medical	1981-12-03	38
K811769	LAPAROTOMY PADS	South Mountain Medical	1981-08-07	46

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