Atlas FDA

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

Dallen Medical, Inc. — Predicate Candidate Screening

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

110 daysmedian FDA review time
172 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K171473Compressyn™ StapleDallen Medical, Inc.2017-11-071720
K150359Tensyn PlugDallen Medical, Inc.2015-05-07840
K143092Tensyn PlugDallen Medical, Inc.2015-02-111060
K141264TENSYN BAND, TENSYN FRACTURE PLATESDallen Medical, Inc.2014-08-21980
K140358COMPRESSYN STAPLEDallen Medical, Inc.2014-06-021100
K133858TENSYN BANDDallen Medical, Inc.2014-02-28710
K132875COMPRESSYN STAPLEDallen Medical, Inc.2013-12-301080
K131850TENSYN BANDDallen Medical, Inc.2013-11-151470
K130431COMPRESSYN BANDDallen Medical, Inc.2013-07-251540
K122871COMPRESSYN STAPLEDallen Medical, Inc.2013-02-071410

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