# Planmed OY

- Location (FDA's records): Helsinki, FI
- FDA decisions: 20 (1992–2025): 20 510(k) clearances
- Product codes: IZH (11), MUE (4), OAS (3), JAK (1), SFV (1)
- 510(k) review time since 2016: median 395 days, against 105 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 17 (12 its own); citations of its devices by later devices: 14 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xoran Technologies, Inc.: 2 (https://510kreport.com/company/xoran-technologies)
- Planmeca USA, Inc.: 2 (https://510kreport.com/company/planmeca-usa)
- Cefla S.C.: 1 (https://510kreport.com/company/cefla-sc)

## Firms that cite its devices most
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)
- Metaltronica Spa: 1 (https://510kreport.com/company/metaltronica)

## Its most-cited devices
- K163328: Planmed Clarity (2017), cited by 2
- K180918: Planmed Verity (2018), cited by 1
- K983659: Planmed Sophie & Planned Sophie Classic (1998), cited by 1
- K143435: Planmed Verity (2015), cited by 1
- K013656: Planmed Sophie & Planmed Sophie Classic (2002), cited by 1
- K121418: Planmed Verity (2013), cited by 1

## Recent decisions
- K250318: Planmed XFI (Sep 26, 2025)
- K211720: Planmed Clarity 2D, Planmed Clarify S (Jul 18, 2022)
- K213278: Planmed Verity (Apr 28, 2022)
- K192317: Planmed Clarity 2D and Clarity S (Oct 23, 2020)
- K180918: Planmed Verity (Nov 30, 2018)
- K163328: Planmed Clarity (Dec 28, 2017)
- K143435: Planmed Verity (May 14, 2015)
- K121418: Planmed Verity (Feb 1, 2013)

Source page: https://510kreport.com/company/planmed