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

Precise Optics — Predicate Candidate Screening

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

79 daysmedian FDA review time
140 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMPrecise Optics2003-04-07900
K935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERPrecise Optics1994-03-161180
K932878PRECISION INTRA-ORAL SCOPESPrecise Optics1994-01-062060
K914084ENDOSCOPESPrecise Optics1992-01-221400
K914184P2020-8-0 BEAM-LIMITING DEVICEPrecise Optics1991-11-27700
K911744PRECISION OPTICS CORPORATION LAPAROSCOPEPrecise Optics1991-07-26990
K903459PRECISION OPTICS ENDOSCOPE ADAPTERPrecise Optics1990-10-26860
K903457PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)Precise Optics1990-10-19790
K903458PRECISION OPTICS IMAGE COUPLERPrecise Optics1990-10-19790
K827087P1808 MOBILE C-ARM IMAGE INTENSIFIERPrecise Optics1982-03-04410
K820178PI808 MOBILE C-ARM IMAGE INTENSIFIERPrecise Optics1982-03-04410
K792307DENTIX DENTAL X-RAY UNITPrecise Optics1980-01-09540
K792225P1806 MOBILE C-ARM IMAGE INTENSIFIERPrecise Optics1979-12-20450

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