Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lina Medical Aps — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
271 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240227 | LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP- | Lina Medical Aps | 2024-08-22 | 209 | 0 |
| K223932 | SafeAir combi (SFR-combi-US) | Lina Medical Aps | 2023-04-26 | 117 | 0 |
| K221085 | LiNA OperaScope Needle | Lina Medical Aps | 2022-09-02 | 142 | 0 |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, | Lina Medical Aps | 2020-01-17 | 81 | 0 |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019-02-07 | 175 | 0 |
| K182354 | SafeAir Telescopic Smoke Pencil | Lina Medical Aps | 2018-12-14 | 107 | 3 |
| K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit | Lina Medical Aps | 2018-01-04 | 265 | 0 |
| K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014-12-04 | 31 | 8 |
| K142757 | LiNA PowerBlade Plus HC | Lina Medical Aps | 2014-10-23 | 28 | 0 |
| K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014-10-06 | 27 | 0 |
| K132135 | LINA GOLD LOOP HC | Lina Medical Aps | 2014-01-31 | 205 | 0 |
| K132837 | LINA POWERBLADE PLUS | Lina Medical Aps | 2013-12-19 | 100 | 0 |
| K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SI | Lina Medical Aps | 2013-07-24 | 169 | 0 |
| K101458 | LINA XCISE MODEL MOR-1515 | Lina Medical Aps | 2011-03-11 | 289 | 0 |
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007-10-30 | 271 | 3 |
| K063025 | LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-15 | Lina Medical Aps | 2006-12-01 | 60 | 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