Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Information Sciences, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
139 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241083 | SIS System | Surgical Information Sciences, Inc. | 2024-06-14 | 56 | 0 |
| K230977 | SIS System | Surgical Information Sciences, Inc. | 2023-05-02 | 27 | 0 |
| K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | 2022-11-21 | 53 | 0 |
| K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | 2021-03-31 | 79 | 0 |
| K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | 2019-09-13 | 21 | 0 |
| K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | 2019-03-19 | 139 | 0 |
| K162830 | SIS Software | Surgical Information Sciences, Inc. | 2017-02-14 | 130 | 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