Atlas FDA

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

Paragon Trade Brands, Inc. · Predicate Candidate Screening

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

72 daysmedian FDA review time
91 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983381VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELSParagon Trade Brands, Inc.1998-10-19240
K981953VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELSParagon Trade Brands, Inc.1998-08-18760
K962954DEODORANT MAXI PADParagon Trade Brands, Inc.1996-10-10720
K962962DEODORANT PANTY LINERParagon Trade Brands, Inc.1996-10-10720
K962953DEODORANT PANTY SHIELDParagon Trade Brands, Inc.1996-10-10720
K953333MENSTRUAL TAMPONParagon Trade Brands, Inc.1995-12-061420
K953668UNSCENTED ULTRATHIN MAXI PADParagon Trade Brands, Inc.1995-11-01860
K953667UNSCENTED CURVED ULTRATHIN MAXI PADSParagon Trade Brands, Inc.1995-11-01860
K953553UNSCENTED MENSTRAL PADParagon Trade Brands, Inc.1995-10-27910
K953517UNSCENTED MENSTRUAL PADParagon Trade Brands, Inc.1995-10-26910
K953700UNSCENTED CURVED MAXI PADParagon Trade Brands, Inc.1995-09-27500
K953666UNSCENTED MENSTRAL PAD WITH WINGSParagon Trade Brands, Inc.1995-09-27510
K953488UNSCENTED MENSTRUAL LINERParagon Trade Brands, Inc.1995-08-09150
K953487UNSCENTED MENSTRUAL SHIELDParagon Trade Brands, Inc.1995-08-09150

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