Atlas FDA

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

Bioderm, Inc. — Predicate Candidate Screening

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

74 daysmedian FDA review time
115 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSINGBioderm, Inc.1999-05-18570
K982778BIODERM FOAM WOUND DRESSINGBioderm, Inc.1998-10-21750
K982939BTF THIN FILM WOUND DRESSINGBioderm, Inc.1998-10-13530
K980451BIODERM CALCIUM ALGINATE DRESSINGBioderm, Inc.1998-04-09630
K973429BIODERM FOAM WOUND DRESSINGBioderm, Inc.1997-12-01820
K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, Inc.1997-01-101000
K963602BIODERM PVP FOAM WOUND DRESSINGBioderm, Inc.1996-10-30510
K951166BIODERM MEDICAL HYDROGEL ISLAND DRESSINGBioderm, Inc.1995-06-21990
K951842BIODERM MEDICAL TRANSPARENT FILM DRESSINGBioderm, Inc.1995-06-12530
K950685BIODERM MEDICAL HYDROCOLLOID WOUND DRESSINGBioderm, Inc.1995-06-091150
K950619BIODERM MEDICAL FOAM WOUND DRESSINGBioderm, Inc.1995-04-25740
K946292BIODERM MEDICAL COMPOSITE WOUND DRESSINGBioderm, Inc.1995-02-06410
K871327D.R.P. THREE STEP WOUND DRESSINGBioderm, Inc.1987-11-092200
K870352RUBYCELL(TM) SYNTHETIC ISLAND DRESSINGBioderm, Inc.1987-02-26280

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