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

Eastmed Enterprises, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time
154 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922019LARYNGOSCOPE RIGIDEastmed Enterprises, Inc.1993-01-262710
K921128ENDOTRACHEAL TUBE STYLETEastmed Enterprises, Inc.1992-06-02840
K914741AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIEDEastmed Enterprises, Inc.1992-02-031080
K903618ROBERTAZZI NASOPHARYNGEAL AIRWAYEastmed Enterprises, Inc.1991-01-081540
K901489MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)Eastmed Enterprises, Inc.1990-04-10120
K890342AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)Eastmed Enterprises, Inc.1989-04-27940
K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADSEastmed Enterprises, Inc.1988-11-14120
K884073LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)Eastmed Enterprises, Inc.1988-10-13160
K88407215 MILLIMETER MALE AND FEMALE ADAPTERSEastmed Enterprises, Inc.1988-10-07100
K882433LARYNGOSCOPE RIGIDEastmed Enterprises, Inc.1988-09-02800
K882434MASK, GAS, ANESTHETICEastmed Enterprises, Inc.1988-06-30160
K880318ROVENSTEIN FORCEPSEastmed Enterprises, Inc.1988-03-21550
K880319MAGILL FORCEPSEastmed Enterprises, Inc.1988-03-21550

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