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Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Optimed Technologies, Inc. — Predicate Candidate Screening

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

253 daysmedian FDA review time
791 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972520OPTIVIEWOptimed Technologies, Inc.1997-09-29840
K955276BOOSTER LITE 4 MOTORIZED SCOOTEROptimed Technologies, Inc.1996-11-043550
K955274BOOSTER LITE 3 MOTORIZED SCOOTEROptimed Technologies, Inc.1996-11-043550
K955275BOOSTER TROPHY 5 MOTORIZED SCOOTEROptimed Technologies, Inc.1996-11-043550
K943598FLEXIBLE FIBER OPTIC LAPAROSCOPESOptimed Technologies, Inc.1994-10-18840
K926597LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)Optimed Technologies, Inc.1994-07-128090
K921942HYSTEROSCOPE (AND ACCESSORIES)Optimed Technologies, Inc.1994-06-247910
K922711FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPEOptimed Technologies, Inc.1994-05-177110
K921985ARTHROSCOPE & ACCESSORIESOptimed Technologies, Inc.1993-06-294270
K922826FLEXIBLE FIBER OPTIC ENDOSCOPEOptimed Technologies, Inc.1993-02-192531
K921883ENDOSCOPEOptimed Technologies, Inc.1992-11-232160
K922937FLEXIBLE FIBER OPTIC ENDOSCOPEOptimed Technologies, Inc.1992-09-14880
K895245FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPEOptimed Technologies, Inc.1989-11-17880
K883337PL 20/20 INFANT VISION TESTEROptimed Technologies, Inc.1988-10-31830
K880661FIBEROPTIC CATHETEROptimed Technologies, Inc.1988-05-02750

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