# Lina Medical Aps

- Location (FDA's records): Glostrup, DK
- FDA decisions: 16 (2006–2024): 16 510(k) clearances
- Product codes: GEI (7), HIH (2), KNF (2), FYD (1), FAJ (1), HIN (1), HET (1), FBK (1)
- 510(k) review time since 2016: median 142 days, against 104 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 21 (6 its own); citations of its devices by later devices: 12 (6 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lna Medical Aps: 2 (https://510kreport.com/company/lna-medical)
- Gyrus Acmi, Inc.: 2 (https://510kreport.com/company/gyrus-acmi)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Buffalo Filter Co., Inc.: 1 (https://510kreport.com/company/buffalo-filter)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- Endosec Corporation: 1 (https://510kreport.com/company/endosec)
- Omnitech Systems, Inc.: 1 (https://510kreport.com/company/omnitech-systems)

## Firms that cite its devices most
- Shanghai AnQing Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/shanghai-anqing-medical-instrument)
- Gyrus Acmi, Inc.: 1 (https://510kreport.com/company/gyrus-acmi)
- A.M.I. Agency For Medical Innovations GmbH: 1 (https://510kreport.com/company/ami-agency-for-medical-innovations)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Atc Technologies, Inc.: 1 (https://510kreport.com/company/atc-technologies)
- Karl Storz SE & CO. KG: 1 (https://510kreport.com/company/karl-storz)

## Its most-cited devices
- K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (2007), cited by 5
- 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 (2018), cited by 2
- K132837: Lina Powerblade Plus (2013), cited by 1
- K142538: LiNA SafeAir Smoke Pencil (2014), cited by 1
- K143145: SafeAir Smoke Pencil (2014), cited by 1
- K101458: Lina Xcise Model  Mor-1515 (2011), cited by 1

## Recent decisions
- K240227: LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) (Aug 22, 2024)
- K223932: SafeAir combi (SFR-combi-US) (Apr 26, 2023)
- K221085: LiNA OperaScope Needle (Sep 2, 2022)
- K193007: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module (Jan 17, 2020)
- K182224: SafeAir Smoke Evacuator compact (Feb 7, 2019)
- K182354: SafeAir Telescopic Smoke Pencil (Dec 14, 2018)
- 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 (Jan 4, 2018)
- K143145: SafeAir Smoke Pencil (Dec 4, 2014)

Source page: https://510kreport.com/company/lina-medical