Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Henry Schein, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
136 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041580 | IMAGERAYI | Henry Schein, Inc. | 2004-06-29 | 15 | 0 |
| K862384 | SCHEIN AP-1 AIR POLISHING UNIT | Henry Schein, Inc. | 1986-11-07 | 136 | 0 |
| K862385 | SCHEIN BLEACHING UNIT | Henry Schein, Inc. | 1986-10-30 | 128 | 0 |
| K841199 | FIBERGLASS MOUTH MIRRORS | Henry Schein, Inc. | 1984-04-25 | 35 | 0 |
| K834055 | VANADIUM EXCAVATORS SIZES 0-6 | Henry Schein, Inc. | 1984-02-21 | 90 | 8 |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Henry Schein, Inc. | 1984-02-03 | 72 | 0 |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | Henry Schein, Inc. | 1980-05-20 | 13 | 0 |
| K781592 | SURGICAL ASPIRATOR TIPS | Henry Schein, Inc. | 1978-12-04 | 77 | 0 |
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