Maxtec, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Maxtec, LLC” (first 2004, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 128 days. Since 2017 the median was 266 days, against 246 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 |
|---|---|---|
| 2012 | 1 | 120 |
| 2013 | 0 | — |
| 2014 | 1 | 130 |
| 2015 | 0 | — |
| 2016 | 2 | 150 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 266 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 224 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Maxtec, LLC took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 246 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 5 | 5 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
Review panels
- Anesthesiology (10)
Most recent Maxtec, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231895 | Maxtec MaxBlend2+p | BZR | 2023-12-04 | 159 |
| K221734 | Maxtec MaxO2 ME+p | CCL | 2023-04-01 | 290 |
| K182362 | MaxCap Ped and MaxCap Neo | CCK | 2019-05-23 | 266 |
| K161718 | MaxBlend 2, MaxBlend Lite | BZR | 2016-10-27 | 127 |
| K153659 | MaxO2ME | CCL | 2016-06-10 | 172 |
| K133540 | FLOCAP | CCK | 2014-03-28 | 130 |
| K113232 | MAXMIXING BLOCK | BZR | 2012-03-01 | 120 |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | CCL | 2011-12-14 | 114 |
| K063488 | MAXO2 CU | CCL | 2007-02-22 | 97 |
| K040484 | MAXO2+, MODEL A AND AE | CCL | 2004-06-09 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Maxtec, LLC.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Maxtec, LLC?
FDA lists 10 510(k) clearances under the applicant name “Maxtec, LLC” (first 2004, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Maxtec, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maxtec, LLC is 128 days. Since 2017: 266 days, versus 246 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Maxtec, LLC?
The most frequent FDA product codes under this applicant name are CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 5); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 3); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2).
Next steps
- See all 10 Maxtec, LLC clearances with predicates and recalls
- Run predicate analysis for product code CCL, Maxtec, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.