Atlas FDA

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

EMH · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

47 daysmedian FDA review time
123 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890256BONE RONGEUR, DOUBLE-ACTIONKinetic Medical Products1989-01-2790
K890255BONE RONGEUR, SINGLE-ACTIONKinetic Medical Products1989-01-2790
K854887MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLATWalter Lorenz Surgical, Inc.1986-02-28840
K851710586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORCArtiberia1985-06-11470
K834190JAKOBI SURG. INSTRUMENTS #8 15Imm Enterprises , Ltd.1984-03-061060
K834366SURGICAL INSTRUMENTS & ACCESSORIESC.B.S. Biotechnics, Inc.1984-02-271230
K821358MODIFIED RONGEURS FOR SPINAL & ORTH. S.Downs Surgical , Ltd.1982-05-28220
K771522FORCEPS, STYLE #849Premier Dental Products Co.1977-08-1680

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