510(k) · Cleared
ClearedHanson Medical Facial Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hanson Medical, Inc. · FZE Prosthesis, Nose, Internal
Cleared on Jun 30, 2010 as substantially equivalent to K973573 (Hanson Medical, Inc., 1997) and 2 other predicates after a 463-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 30, 2010
- Review
- 463 days
- Class
- Class II
- Product code
- FZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K952705 (1995). 7 ancestors in all, the oldest K952707 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK952705 Spirit Ridge Nasal ImplantSpirit Ridge Technologies · 1995
- 2 generations backK971481 Duralastic Anatomical Nasal ImplantsAllied Biomedical Corp. · 1997
- 1 generation backK973573 Duralastic Anatomical Nasal ImplantsHanson Medical, Inc. · 1997
- This deviceK090803 Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952705 | Spirit Ridge Nasal Implant | Spirit Ridge Technologies | 1995 | — |
| −2 | K971481 | Duralastic Anatomical Nasal Implants | Allied Biomedical Corp. | 1997 | — |
| −1 | K973573 | Duralastic Anatomical Nasal Implants | Hanson Medical, Inc. | 1997 | — |
| 0 (this device) | K090803 | Hanson Medical Facial Implants | Hanson Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FZE device
- #1 K241253 Medicon Epiplating Systemscore 9.1 · 3 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973573 | Duralastic Anatomical Nasal ImplantsSummary page 3…Radiological Health Enclosure TAB D INTENDED USE FORM 5 10(k) Number K 973573 Silicone Nasal Implant K 973574 Silicone Malar Implant K 973575 Silicone Chin Implant Device Name:… | 1997 |
| * | K973574 | Duralastic Anatomical Malar ImplantSummary page 3…e 3 === TAB D INTENDED USE FORM 5 10(k) Number K 973573 Silicone Nasal Implant K 973574 Silicone Malar Implant K 973575 Silicone Chin Implant Device Name: Hanson Medical Facial Implants Indications fo… | 1997 |
| * | K973575 | Duralastic Anatomical Chin ImplantsSummary page 3…TAB D INTENDED USE FORM 5 10(k) Number K 973573 Silicone Nasal Implant K 973574 Silicone Malar Implant K 973575 Silicone Chin Implant Device Name: Hanson Medical Facial Implants Indications for use: Silicone Nasal Implant - For the augmen… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All FZE devicesFZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FZE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FZE
Too few FZE 510(k)s in any year since 2007 to give a median.
Recalls per year · FZE
No recall names FZE since 2007.
Adverse event reports per year · FZE
13in 2025
MAUDE reports naming product code FZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour
Silicone Malar Implant - For the augmentation or reconstruction of the malar contour
Silicone Chin Implant -For the augmentation or reconstruction of the chin contour
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090803: Hanson Medical Facial Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090803
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026