Atlas FDA

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

Biogennix, LLC · Predicate Candidate Screening

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

175 daysmedian FDA review time
293 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240621Morpheus® Moldable; Agilon® MoldableBiogennix, LLC2024-04-30560
K193487Agilon StripBiogennix, LLC2020-03-301040
K193168Agilon MoldableBiogennix, LLC2020-02-13900
K190371Morpheus-CBiogennix, LLC2019-08-091750
K181337Sypher Spacer SystemBiogennix, LLC2018-09-181200
K141798SYPHER SPACER SYSTEMBiogennix, LLC2015-02-192310
K132377OSTEOSPAN MORPHEUSBiogennix, LLC2014-05-202930
K093342BIOGENNIX RPCBiogennix, LLC2010-07-292760

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