Atlas FDA

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

Zomed Intl. — Predicate Candidate Screening

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

70 daysmedian FDA review time
155 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964286ZOMED PASSIVE TEMPERATURE PROBEZomed Intl.1996-11-19220
K962692ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBEZomed Intl.1996-09-19700
K960695MODEL 200C ELECTROSURGICAL PROBEZomed Intl.1996-04-30700
K960694ZOMED 30F ELECTROSURGICAL PROBEZomed Intl.1996-04-30700
K954965ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBESZomed Intl.1995-12-18490
K952072ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSZomed Intl.1995-10-041550
K951659ZOMED MODEL 10 CAUTERY BIOPSY DEVICEZomed Intl.1995-06-19700

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