Lina Medical Aps: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Lina Medical Aps” (first 2006, latest 2024), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 130 days. Since 2017 the median was 142 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 134 |
| 2014 | 4 | 30 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 186 |
| 2019 | 1 | 175 |
| 2020 | 1 | 81 |
| 2021 | 0 | — |
| 2022 | 1 | 142 |
| 2023 | 1 | 117 |
| 2024 | 1 | 209 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lina Medical Aps took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 | 7 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 | 1 |
Review panels
- General and Plastic Surgery (7)
- Obstetrics and Gynecology (6)
- Gastroenterology and Urology (2)
- General Hospital (1)
Most recent Lina Medical Aps 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | FAJ | 2024-08-22 | 209 |
| K223932 | SafeAir combi (SFR-combi-US) | GEI | 2023-04-26 | 117 |
| K221085 | LiNA OperaScope Needle | FBK | 2022-09-02 | 142 |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | HIH | 2020-01-17 | 81 |
| K182224 | SafeAir Smoke Evacuator compact | FYD | 2019-02-07 | 175 |
| K182354 | SafeAir Telescopic Smoke Pencil | GEI | 2018-12-14 | 107 |
| K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | HIH | 2018-01-04 | 265 |
| K143145 | SafeAir Smoke Pencil | GEI | 2014-12-04 | 31 |
| K142757 | LiNA PowerBlade Plus HC | GEI | 2014-10-23 | 28 |
| K142538 | LiNA SafeAir Smoke Pencil | GEI | 2014-10-06 | 27 |
6 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-12-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lina Medical Cml Aps (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lina Medical Aps?
FDA lists 16 510(k) clearances under the applicant name “Lina Medical Aps” (first 2006, latest 2024), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lina Medical Aps?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lina Medical Aps is 130 days. Since 2017: 142 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lina Medical Aps?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); HIH (Hysteroscope (And Accessories), 2); KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), 2).
Next steps
- See all 16 Lina Medical Aps clearances with predicates and recalls
- Run predicate analysis for product code GEI, Lina Medical Aps's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.