Htl-Strefa S.A: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Htl-Strefa S.A” (first 2015, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 216 days, against 116 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 |
|---|---|---|
| 2015 | 1 | 206 |
| 2016 | 0 | — |
| 2017 | 1 | 253 |
| 2018 | 1 | 264 |
| 2019 | 0 | — |
| 2020 | 2 | 161 |
| 2021 | 0 | — |
| 2022 | 1 | 126 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 179 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Htl-Strefa S.A took a median 216 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 5 | 5 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 1 | 1 |
Review panels
Most recent Htl-Strefa S.A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250016 | droplet® personal lancets | QRK | 2025-07-01 | 179 |
| 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 | 2022-07-08 | 126 |
| K202340 | Droplet Pen Needle 30G & 33G | FMI | 2020-10-15 | 59 |
| K192082 | Droplet Pen Needle 34G | FMI | 2020-04-21 | 263 |
| K171982 | DROPLET PEN NEEDLE | FMI | 2018-03-21 | 264 |
| K170988 | DropSafe Safety Pen Needle | FMI | 2017-12-12 | 253 |
| K143437 | Droplet Pen Needles | FMI | 2015-06-25 | 206 |
Recalls
openFDA lists no recalls under a recalling firm named Htl-Strefa S.A.
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.
Device clinical trials
An industry sponsor named Htl-Strefa S.A is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04933461: Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C) (Completed, started 2019-09-24)
- NCT03811444: Simulated Clinical Use Testing On Safety Lancets (Test B) (Completed, started 2018-11-30)
- NCT03807635: Simulated Clinical Use Testing on Safety Lancets (Test A) (Completed, started 2018-11-30)
- NCT03479619: Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity. (Completed, started 2018-03-06)
- NCT03752229: Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets (Completed, started 2017-12-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Htl-Strefa S.A?
FDA lists 7 510(k) clearances under the applicant name “Htl-Strefa S.A” (first 2015, latest 2025), across 3 product codes in 2 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 Htl-Strefa S.A?
The median time from FDA receipt to decision across 510(k)s cleared under the name Htl-Strefa S.A is 206 days. Since 2017: 216 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Htl-Strefa S.A?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 5); FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 1); QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, 1).
Next steps
- See all 7 Htl-Strefa S.A clearances with predicates and recalls
- Run predicate analysis for product code FMI, Htl-Strefa S.A'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.