Atlas FDA

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

Allied Biomedical Corp. — Predicate Candidate Screening

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

78 daysmedian FDA review time
86 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982051KELOCATE SHEETINGAllied Biomedical Corp.1998-08-05550
K971479DURALASTIC ANATOMICAL MALAR IMPLANTSAllied Biomedical Corp.1997-07-18860
K971481DURALASTIC ANATOMICAL NASAL IMPLANTSAllied Biomedical Corp.1997-07-18860
K971478DURALASTIC ANATOMICAL CHIN IMPLANTSAllied Biomedical Corp.1997-07-18860
K971480DURALASTIC I AND DURALASTIC IIAllied Biomedical Corp.1997-05-28350
K955368DURALASTIC IAllied Biomedical Corp.1996-02-08780
K955370DURALASTIC IIAllied Biomedical Corp.1996-02-08780
K955433DURALASTIC SILICONE TUBINGAllied Biomedical Corp.1996-01-26590
K954413KELOCOTEAllied Biomedical Corp.1995-11-29690

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