Atlas FDA

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

LYF · Predicate Candidate Screening

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

104 daysmedian FDA review time
203 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992252LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965Chemicon Intl., Inc.1999-08-10350
K923349FUNGI FLUOR KITPolysciences, Inc.1992-10-201040
K905504STAINING SYSTEM FOR PNEUMOCYSTIS CARINIIDako Corp.1991-06-282030
K904400MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONMeridian Diagnostics, Inc.1990-10-16250
K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.1989-03-21340
K884047FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAYDisease Detection International, Inc.1989-03-141690
K881608MERIFLUOR(TM) PNEUMOCYSTISMeridian Diagnostics, Inc.1988-08-041140

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