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

Spectrum Designs, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
90 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992522SPECTRUM DESIGNS SPECTRAGELSpectrum Designs, Inc.1999-10-26900
K982688SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCKSpectrum Designs, Inc.1998-10-13710
K980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTSpectrum Designs, Inc.1998-05-06900
K980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTSpectrum Designs, Inc.1998-05-06900
K980462SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANTSpectrum Designs, Inc.1998-05-06900
K980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTSpectrum Designs, Inc.1998-05-06900
K980446SPECTRUM DESIGNS ANTERIOR CHIN IMPLANTSpectrum Designs, Inc.1998-05-06900
K980138SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANTSpectrum Designs, Inc.1998-04-03780
K980461SPECTRUM DESIGNS CLEFT CHIN IMPLANTSpectrum Designs, Inc.1998-03-04270
K980139SPECTRUM DESIGNS PROFILE MALAR IMPLANTSpectrum Designs, Inc.1998-03-03470
K980141SPECTRUM DESIGNS PROJECTION MALAR IMPLANTSpectrum Designs, Inc.1998-03-03470
K980140SPECTRUM DESIGNS MEDIAL MALAR IMPLANTSpectrum Designs, Inc.1998-03-03470
K970702SPECTRUM DESIGNS SPECTRAGELSpectrum Designs, Inc.1997-05-12750
K960038SPECTRUM DESIGNS SILICONE BLOCKSpectrum Designs, Inc.1996-03-13700
K944163SPECTRUM DISIGNS PECTORAL IMPLANTSpectrum Designs, Inc.1994-11-07730
K944165SILHOUETTE MALAR IMPLANTSpectrum Designs, Inc.1994-11-04701
K944166DORSAL COLUMELLA IMPLANTSpectrum Designs, Inc.1994-11-04700
K944164MENISCUS CHIN IMPLANTSpectrum Designs, Inc.1994-11-04700

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