Atlas FDA

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

Spiracur, Inc. — Predicate Candidate Screening

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

102 daysmedian FDA review time
277 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151710SNaP Wound Care SystemSpiracur, Inc.2015-11-191480
K142272SNaP Wound Care SystemSpiracur, Inc.2014-11-251020
K132080SNAP WOUND CARE SYSTEMSpiracur, Inc.2014-03-122500
K133137CISNAP CLOSED INCISION SYSTEMSpiracur, Inc.2014-02-251370
K113032SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-12-01500
K112341SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-08-29140
K111393SNAP (R) WOUND CARE SYSTEMSpiracur, Inc.2011-07-28710
K111006CI-SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-07-211010
DEN080011SNAP WOUND CARE DEVICESpiracur, Inc.2009-08-072770

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