Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
7D Surgical, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
257 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin G | 7D Surgical, Inc. | 2021-06-21 | 125 | 0 |
| K210555 | 7D Surgical System - Drill Guide | 7D Surgical, Inc. | 2021-03-23 | 26 | 0 |
| K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5. | 7D Surgical, Inc. | 2020-09-03 | 50 | 0 |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter P | 7D Surgical, Inc. | 2019-11-27 | 40 | 0 |
| K192140 | 7D Surgical System | 7D Surgical, Inc. | 2019-11-05 | 89 | 0 |
| K183276 | 7D Surgical System | 7D Surgical, Inc. | 2019-08-07 | 257 | 0 |
| K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | 2018-08-08 | 111 | 0 |
| K180352 | 7D Surgical System | 7D Surgical, Inc. | 2018-05-02 | 83 | 0 |
| K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | 2016-12-29 | 127 | 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