Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microline Surgical, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
232 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); R | Microline Surgical, Inc. | 2024-04-23 | 116 | 0 |
| K213127 | ReNew Disposable Scissor Tips | Microline Surgical, Inc. | 2022-03-02 | 156 | 1 |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpi | Microline Surgical, Inc. | 2020-10-21 | 105 | 0 |
| K160706 | ReNew V Handpiece Laparoscopic Instruments | Microline Surgical, Inc. | 2016-10-19 | 219 | 0 |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709) | Microline Surgical, Inc. | 2016-05-12 | 232 | 0 |
| K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | Microline Surgical, Inc. | 2016-02-08 | 138 | 0 |
| K124029 | MICROLINE FLEXIBLE LIGATING SHEARS | Microline Surgical, Inc. | 2013-03-27 | 89 | 0 |
| K122086 | THERMAL LIGATING SHEARS | Microline Surgical, Inc. | 2012-08-23 | 38 | 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