510(k) · Cleared
ClearedDuralastic Anatomical Nasal 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 Nov 13, 1997 as substantially equivalent to K971481 (Allied Biomedical Corp., 1997) after a 55-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Nov 13, 1997
- Review
- 55 days
- Class
- Class II
- Product code
- FZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952705 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK952705 Spirit Ridge Nasal ImplantSpirit Ridge Technologies · 1995
- 1 generation backK971481 Duralastic Anatomical Nasal ImplantsAllied Biomedical Corp. · 1997
- This deviceK973573 Duralastic Anatomical Nasal ImplantsHanson Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK090803 Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K090803Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952705 | Spirit Ridge Nasal Implant | Spirit Ridge Technologies | 1995 | — |
| −1 | K971481 | Duralastic Anatomical Nasal Implants | Allied Biomedical Corp. | 1997 | — |
| 0 (this device) | K973573 | Duralastic Anatomical Nasal Implants | Hanson Medical, Inc. | 1997 | — |
| +1 | K090803 | Hanson Medical Facial Implants | Hanson Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
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 |
|---|---|---|---|
| * | K971481 | Duralastic Anatomical Nasal ImplantsSummary page 1…nts are used to make the white and flesh tone versions of these implants. SUBSTANTIAL EQUIVALENCE Duralastic Nasal Implants are SE to Allied Biomedical Nasal Implants, K971481. They will be produced in the exact sizes and shapes as the Allied Predicate device. INTENDED USE Duralastic Nasal implants are… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090803 | Hanson Medical Facial Implants | 2010 | 0 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090803 (Hanson Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FZE devicesFZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To augment or reconstruct the nasal contour
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973573: Duralastic Anatomical Nasal Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973573
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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