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

Gauss Surgical, Inc., — Predicate Candidate Screening

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

164 daysmedian FDA review time

459 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163507	Triton Sponge System	Gauss Surgical, Inc.,	2017-04-25	132	0
K160338	Triton System	Gauss Surgical, Inc.,	2016-08-05	179	0
K142801	Triton Canister System	Gauss Surgical, Inc.,	2015-03-12	164	3
DEN130015	PIXEL 3 SYSTEM	Gauss Surgical, Inc.,	2014-05-09	459	0
K121274	PIXEL APP	Gauss Surgical, Inc.,	2012-06-27	61	0
K120473	PIXEL APP	Gauss Surgical, Inc.,	2012-04-09	53	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