Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Puritan Medical Products, LLC · Predicate Candidate Screening

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

137 daysmedian FDA review time
251 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC2025-05-272510
K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC2016-11-04810
K160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystePuritan Medical Products, LLC2016-07-291960
K142366Puritan OptiTranz Liquid Stuart Collection and Transport SysPuritan Medical Products, LLC2015-01-091370
K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLC2013-10-211390
K120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC2012-06-08800
K113249TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC2012-03-011190

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