Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Htl-Strefa S.A — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
264 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250016 | droplet® personal lancets | Htl-Strefa S.A | 2025-07-01 | 179 | 0 |
| K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safet | Htl-Strefa S.A | 2022-07-08 | 126 | 0 |
| K202340 | Droplet Pen Needle 30G & 33G | Htl-Strefa S.A | 2020-10-15 | 59 | 0 |
| K192082 | Droplet Pen Needle 34G | Htl-Strefa S.A | 2020-04-21 | 263 | 0 |
| K171982 | DROPLET PEN NEEDLE | Htl-Strefa S.A | 2018-03-21 | 264 | 0 |
| K170988 | DropSafe Safety Pen Needle | Htl-Strefa S.A | 2017-12-12 | 253 | 0 |
| K143437 | Droplet Pen Needles | Htl-Strefa S.A | 2015-06-25 | 206 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda