Atlas FDA

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

OKO — Predicate Candidate Screening

17 FDA 510(k) clearances under this product code; the 50 most recent screened below.

101 daysmedian FDA review time
250 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251156NPsealGuard Medical, Inc.2025-05-15300
K250708NPsealGuard Medical, Inc.2025-04-08290
K241522NPseal (20 and 25)Guard Medical, Inc.2024-08-15780
K240244NPseal (Small, Medium, Large)Guard Medical, Inc.2024-02-29300
K212971NPsealGuard Medical, Inc.2022-02-101460
K211130NPsealGuard Medical, Inc.2021-05-14280
K200305NPsealGuard Medical, Inc.2020-05-261100
K193185Anscare SIMO Negative Pressure Wound Therapy (NPWT) SystemBenq Materials Corporation2020-05-041680
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