HTL-Strefa S.A.
Woodstock, GA, US
HTL-STREFA S.A. appears in FDA device records in Woodstock, GA. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for HTL-Strefa S.A. between 2015 and 2025. The busiest year on record is 2020, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
| 2022 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250016 | droplet® personal lancets | QRK | Substantially Equivalent | |
| 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 | FMK | Substantially Equivalent | |
| K211716 | DropSafe Safety Pen Needles | FMI | Substantially Equivalent | |
| K202340 | Droplet Pen Needle 30G & 33G | FMI | Substantially Equivalent | |
| K192082 | Droplet Pen Needle 34G | FMI | Substantially Equivalent | |
| K171982 | DROPLET PEN NEEDLE | FMI | Substantially Equivalent | |
| K170988 | DropSafe Safety Pen Needle | FMI | Substantially Equivalent | |
| K143437 | Droplet Pen Needles | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613304 | 3004034544 | HTL-STREFA S.A. | ADAMOWEK 7, OZORKOW Lodzkie 95-035 PL | 2026 | |
| 3006142663 | 3006142663 | HTL-STREFA, INC. | 113 Towne Lake Pkwy Ste 120, Woodstock, GA 30188 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FLLContinuous Measurement Thermometer
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- FMINeedle, Hypodermic, Single Lumen
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- MEGSyringe, Antistick
- FMFSyringe, Piston
- KGXTape And Bandage, Adhesive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain