# Htl-Strefa S.A

- Location (FDA's records): Ozorkow, PL
- FDA decisions: 7 (2015–2025): 7 510(k) clearances
- Product codes: FMI (5), FMK (1), QRK (1)
- 510(k) review time since 2016: median 253 days, against 253 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 9 (2 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
- Becton, Dickinson & CO: 3 (https://510kreport.com/company/becton-dickinson)
- Kofu Factory of Terumo Corp.: 1 (https://510kreport.com/company/kofu-factory-of-terumo)
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)
- SteriLance Medical (Suzhou), Inc.: 1 (https://510kreport.com/company/sterilance-medical-suzhou)

## Firms that cite its devices most
- Tianjin Huahong Technology Co., Ltd.: 2 (https://510kreport.com/company/tianjin-huahong-technology)
- Gangan Medical Technology Jiangsu Co., Ltd.: 1 (https://510kreport.com/company/gangan-medical-technology-jiangsu)
- Pikdare Spa: 1 (https://510kreport.com/company/pikdare)
- Htl Strefa SA: 1 (https://510kreport.com/company/htl-strefa)
- Jiangsu Caina Medical Co.,Ltd: 1 (https://510kreport.com/company/jiangsu-caina-medical)
- CMT Health PTE., Ltd.: 1 (https://510kreport.com/company/cmt-health)

## Its most-cited devices
- K171982: Droplet Pen Needle (2018), cited by 3
- K170988: DropSafe Safety Pen Needle (2017), cited by 3
- K192082: Droplet Pen Needle 34G (2020), cited by 2
- K143437: Droplet Pen Needles (2015), cited by 1

## Recent decisions
- K250016: droplet® personal lancets (Jul 1, 2025)
- K220643: DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets (Jul 8, 2022)
- K202340: Droplet Pen Needle 30G & 33G (Oct 15, 2020)
- K192082: Droplet Pen Needle 34G (Apr 21, 2020)
- K171982: Droplet Pen Needle (Mar 21, 2018)
- K170988: DropSafe Safety Pen Needle (Dec 12, 2017)
- K143437: Droplet Pen Needles (Jun 25, 2015)

Source page: https://510kreport.com/company/htl-strefa-s-a