Hanson Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Hanson Medical, Inc.” (first 1997, latest 2014), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 47 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 29 |
| 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 |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | 4 | 4 |
| MIB | Elastomer, Silicone Block | 4 | 4 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| DXX | System, Catheter Control, Steerable | 1 | 1 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
| MIC | Implant, Muscle, Pectoralis | 1 | 1 |
Review panels
Most recent Hanson Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM | DXX | 2014-08-05 | 29 |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | FZE | 2010-06-30 | 463 |
| K071018 | MONARCH NASAL IMPLANT | FZE | 2007-05-25 | 45 |
| K041690 | MONARCH NASAL IMPLANT | FZE | 2005-02-11 | 234 |
| K040307 | HANSON SCAR ADE | MDA | 2004-08-12 | 185 |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | MIB | 2003-04-21 | 39 |
| K030808 | HANSON MEDICAL CALF IMPLANT | MIB | 2003-04-21 | 39 |
| K973730 | DURASIL I AND DURASIL II | MIB | 1997-12-24 | 85 |
| K973729 | POWERFLEX PEC IMPLANT | MIC | 1997-12-24 | 85 |
| K973728 | SILICONE CARVING BLOCK | MIB | 1997-11-13 | 44 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hanson Medical, Inc..
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.
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.
- Hanson Scale Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hanson Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Hanson Medical, Inc.” (first 1997, latest 2014), across 7 product codes in 2 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 Hanson Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hanson Medical, Inc. is 47 days.
Which FDA product codes appear under Hanson Medical, Inc.?
The most frequent FDA product codes under this applicant name are FZE (Prosthesis, Nose, Internal, 4); MIB (Elastomer, Silicone Block, 4); MDA (Elastomer, Silicone, For Scar Management, 2).
Next steps
- See all 14 Hanson Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FZE, Hanson Medical, Inc.'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.