Atlas FDA

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

Reznik Instruments — Predicate Candidate Screening

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

70 daysmedian FDA review time
83 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K812205FORCEPReznik Instruments1981-10-26830
K812201PHOTOGRAPHIC EQUIPMENTReznik Instruments1981-10-19760
K812204UTERINE MANIPULATORSReznik Instruments1981-10-13700
K812199TROCAR & TROCAR SLEEVESReznik Instruments1981-10-13700
K812206LAPAROSCOPEReznik Instruments1981-10-13700
K812203ELECTROSURGICAL UNITReznik Instruments1981-10-13700
K812202FIBER OPTIC LIGHT SOURCEReznik Instruments1981-09-29560
K812200INSUFFLATORReznik Instruments1981-09-29560
K812198ACCESSORIES(PROBES, SUCTION TUBES, ETC.)Reznik Instruments1981-09-11380

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