Maxigen Biotech, Inc.: FDA clearances and approvals
Maxigen Biotech, Inc. has 5 FDA 510(k) clearances (first 2011, latest 2026), across 3 product codes in 3 review panels. Median 510(k) review time: 303 days. Since 2017 its median was 320 days, against 157 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 9 device clinical trials on ClinicalTrials.gov.
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 | 2 | 320 |
| 2024 | 0 | — |
| 2025 | 1 | 455 |
| 2026 | 1 | 265 |
Review time against the same product codes
Since 2017, Maxigen Biotech, Inc.'s cleared 510(k)s took a median 320 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 3 | 3 |
| NUC | Lubricant, Personal | 1 | 1 |
| OLR | Oral Wound Dressing | 1 | 1 |
Review panels
Most recent Maxigen Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | NUC | 2026-09-03 | 265 |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | KGN | 2025-10-16 | 455 |
| K230529 | HealiAid Dental Collagen Wound Dressing | OLR | 2023-11-22 | 268 |
| K223126 | SurgiAid® Collagen Wound Dressing | KGN | 2023-10-11 | 373 |
| K100927 | SURGIAID | KGN | 2011-02-02 | 303 |
Recalls
openFDA lists no recalls under a recalling firm named Maxigen Biotech, 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.
Device clinical trials
Maxigen Biotech, Inc. is the industry lead sponsor of 9 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07209020: HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery (Recruiting, started 2025-05-20)
- NCT06994546: ArtiBest for Knee Osteoarthritis (Recruiting, started 2025-03-11)
- NCT06252935: Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration (Recruiting, started 2024-07-30)
- NCT05881317: ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study (Completed, started 2021-08-02)
- NCT05881330: ArtiAid® for Knee Osteoarthritis: A Post-market Study (Completed, started 2021-07-01)
Frequently asked questions
How many FDA 510(k) clearances does Maxigen Biotech, Inc. have?
Maxigen Biotech, Inc. has 5 FDA 510(k) clearances (first 2011, latest 2026), across 3 product codes in 3 review panels.
How long does FDA take to clear Maxigen Biotech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Maxigen Biotech, Inc.'s cleared 510(k)s is 303 days. Since 2017: 320 days, versus 157 days for all cleared 510(k)s in the same product codes.
What devices does Maxigen Biotech, Inc. make?
Its most frequent FDA product codes are KGN (Wound Dressing With Animal-Derived Material(S), 3); NUC (Lubricant, Personal, 1); OLR (Oral Wound Dressing, 1).
Has Maxigen Biotech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Maxigen Biotech, Inc. Related entities may recall under other names.
Next steps
- See all 5 Maxigen Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGN, Maxigen Biotech, 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.