Atlas FDA

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

Gen-Probe Prodesse, Inc. — Predicate Candidate Screening

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

39 daysmedian FDA review time
89 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132238PROPARAFLU+ ASSAYGen-Probe Prodesse, Inc.2013-08-26390
K132237PRODESSE PROFAST+ ASSAYGen-Probe Prodesse, Inc.2013-08-26390
K132200PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.2013-08-14290
K132159PROADENO+ ASSAYGen-Probe Prodesse, Inc.2013-08-14330
K132129PRODESSE PROFLU+ ASSAYGen-Probe Prodesse, Inc.2013-08-09300
K123274PROGASTRO SSCS ASSAYGen-Probe Prodesse, Inc.2013-01-16890
K123838PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.2013-01-16340
K110968PROFLU+ ASSAYGen-Probe Prodesse, Inc.2011-06-27820
K102952PRODESSE PROADENOGen-Probe Prodesse, Inc.2010-12-03590
K101855PROFAST+ ASSAYGen-Probe Prodesse, Inc.2010-07-23220

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