Level 1 Technologies, Inc.: FDA clearances and approvals
Level 1 Technologies, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1996), across 5 product codes in 4 review panels. Median 510(k) review time: 203 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 | 1 |
Review panels
- General Hospital (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Level 1 Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942844 | LEVEL 1 BLOOD STREAM RECOVERY SYSTEM | CAC | 1996-04-26 | 680 |
| K942271 | LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE | FPA | 1995-07-12 | 428 |
| K936223 | PRESSURE IRRIGATING SYSTEM | GCY | 1994-05-12 | 134 |
| K911383 | HOTLINE FLUID WARMER | LGZ | 1991-10-17 | 203 |
| K873435 | LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET | KOD | 1987-10-05 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Level 1 Technologies, Inc..
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 Level 1 Technologies, Inc. have?
Level 1 Technologies, Inc. has 5 FDA 510(k) clearances (first 1987, latest 1996), across 5 product codes in 4 review panels.
How long does FDA take to clear Level 1 Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Level 1 Technologies, Inc.'s cleared 510(k)s is 203 days.
What devices does Level 1 Technologies, Inc. make?
Its most frequent FDA product codes are CAC (Apparatus, Autotransfusion, 1); FPA (Set, Administration, Intravascular, 1); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 1).
Has Level 1 Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Level 1 Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Level 1 Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAC, Level 1 Technologies, Inc.'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.