Hans Biomed Corporation: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hans Biomed Corporation” (first 2012, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 303 days. Since 2017 the median was 320 days, against 106 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 | 332 |
| 2013 | 1 | 138 |
| 2014 | 1 | 345 |
| 2015 | 0 | — |
| 2016 | 2 | 286 |
| 2017 | 0 | — |
| 2018 | 1 | 268 |
| 2019 | 0 | — |
| 2020 | 1 | 371 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 375 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 263 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hans Biomed Corporation 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 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 4 | 4 |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 | 1 |
| NUN | Bone Grafting Material, Human Source | 1 | 1 |
Review panels
- Orthopedic (4)
- General and Plastic Surgery (4)
- Dental (1)
Most recent Hans Biomed Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254238 | MINT MONO Sutures | NEW | 2026-09-18 | 263 |
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | NEW | 2023-03-07 | 375 |
| K192423 | MINT Product Family | NEW | 2020-09-09 | 371 |
| K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | MQV | 2018-02-22 | 268 |
| K152077 | MaxiGen | MQV | 2016-04-21 | 269 |
| K151271 | BellaFuse | MQV | 2016-03-11 | 303 |
| K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | NUN | 2014-01-10 | 345 |
| K130191 | MINT | NEW | 2013-06-12 | 138 |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | MBP | 2012-11-15 | 332 |
Recalls
openFDA lists no recalls under a recalling firm named Hans Biomed Corporation.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hans Biomed Corporation (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hans Rudolph, Inc. (11 510(k)s)
- Hans Hermann GmbH (2 510(k)s)
- Hans J. Brouwers & Assoc. (2 510(k)s)
- Hans Gevder (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hans Biomed Corporation?
FDA lists 9 510(k) clearances under the applicant name “Hans Biomed Corporation” (first 2012, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hans Biomed Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hans Biomed Corporation is 303 days. Since 2017: 320 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hans Biomed Corporation?
The most frequent FDA product codes under this applicant name are NEW (Suture, Surgical, Absorbable, Polydioxanone, 4); MQV (Filler, Bone Void, Calcium Compound, 3); MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), 1).
Next steps
- See all 9 Hans Biomed Corporation clearances with predicates and recalls
- Run predicate analysis for product code NEW, Hans Biomed Corporation'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.