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

Metatech Corp. — Predicate Candidate Screening

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

75 daysmedian FDA review time
90 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K924314MOBILE STANDING FRAMEMetatech Corp.1993-02-121700
K915370COPPER VAPOR LASER SYSTEMMetatech Corp.1992-02-07720
K903883VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LESMetatech Corp.1990-09-19280
K890865HEXASCAN SCANNER HANDPIECEMetatech Corp.1989-03-24310
K883541METALASER VASCULASEMetatech Corp.1988-11-04770
K883881MODIFIED MODEL 2001 FIBER OPTICS CATHETERMetatech Corp.1988-10-27900
K883518EVENT MARKER & A SECOND PRESSURE TREND OUTPUTMetatech Corp.1988-09-22370
K882552METATECH ROBINSON BOLT ACCESSORYMetatech Corp.1988-09-08790
K882367METATECH MICROCLIP APPLICATORMetatech Corp.1988-08-25780
K882286EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SETMetatech Corp.1988-07-18470
K881447METATECH METAL MICROCLIPMetatech Corp.1988-06-22770
K880154METATECH INTRACRANIAL PRESSURE MONITORING SYSTEMMetatech Corp.1988-03-28750
K850538BED SENTRY, MODEL 50UMetatech Corp.1985-04-03510

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