Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IDO — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
85 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864733 | LKB 2260 MACROTOME | Lkb Instruments, Inc. | 1987-01-05 | 32 | 0 |
| K863548 | ROTARY MICROTOME | Surgipath Medical Industries, Inc. | 1986-09-19 | 7 | 0 |
| K843505 | LKB 2230 ROTARY ONE | Lkb Instruments, Inc. | 1984-11-30 | 85 | 0 |
| K812558 | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | Miles Laboratories, Inc. | 1981-09-29 | 21 | 0 |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | Lkb Instruments, Inc. | 1981-08-18 | 20 | 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