Assure Tech., LLC: FDA clearances and approvals
Assure Tech., LLC has 10 FDA 510(k) clearances (first 2015, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time: 39 days. Since 2017 its median was 35 days, against 65 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 52 |
| 2016 | 1 | 153 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 4 | 36 |
| 2026 | 2 | 62 |
Review time against the same product codes
Since 2017, Assure Tech., LLC's cleared 510(k)s took a median 35 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 65 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | 3 | 3 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| NGL | Test, Opiates, Over The Counter | 1 | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 | 1 |
Review panels
Most recent Assure Tech., LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | NFT | 2026-07-17 | 35 |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | QYT | 2026-06-05 | 88 |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | NFT | 2025-08-15 | 25 |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | LCX | 2025-02-13 | 28 |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | NFT | 2025-02-07 | 43 |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | LCX | 2025-01-15 | 57 |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | NGL | 2024-03-06 | 30 |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | JHI | 2016-02-24 | 153 |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | DJR | 2015-10-05 | 75 |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | DIS | 2015-06-04 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Assure Tech., LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Assure Tech., LLC have?
Assure Tech., LLC has 10 FDA 510(k) clearances (first 2015, latest 2026), across 7 product codes in 3 review panels.
How long does FDA take to clear Assure Tech., LLC's 510(k)s?
The median time from FDA receipt to decision across Assure Tech., LLC's cleared 510(k)s is 39 days. Since 2017: 35 days, versus 65 days for all cleared 510(k)s in the same product codes.
What devices does Assure Tech., LLC make?
Its most frequent FDA product codes are NFT (Test, Amphetamine, Over The Counter, 3); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2); DIS (Enzyme Immunoassay, Barbiturate, 1).
Has Assure Tech., LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Assure Tech., LLC. Related entities may recall under other names.
Next steps
- See all 10 Assure Tech., LLC clearances with predicates and recalls
- Run predicate analysis for product code NFT, Assure Tech., LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.