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

Snap Laboratories, LLC — Predicate Candidate Screening

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

205 daysmedian FDA review time
405 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080321SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEMSnap Laboratories, LLC2008-05-231070
K002095SNAP MODEL 6Snap Laboratories, LLC2001-03-022340
K992322SNAP MODEL 5Snap Laboratories, LLC2000-02-022050
K984169DIGI-SNAPSnap Laboratories, LLC1999-05-261870
K971184OXI-SNAPSnap Laboratories, LLC1997-10-011830
K944524SNAP TESTING DEVICESnap Laboratories, LLC1995-10-264050

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