Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sectra AB — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
265 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | 2024-04-16 | 265 | 0 |
| K193054 | Sectra Digital Pathology Module | Sectra AB | 2020-03-31 | 151 | 0 |
| K034059 | SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE | Sectra AB | 2004-03-09 | 69 | 0 |
| K033088 | SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 | Sectra AB | 2003-10-29 | 30 | 1 |
| K001140 | IDS5 IMAGE DISPLAY SYSTEM | Sectra AB | 2000-05-03 | 23 | 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