510(k) · Cleared
ClearedDuralastic Anatomical Nasal Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allied Biomedical Corp. · FZE Prosthesis, Nose, Internal
Cleared on Jul 18, 1997 as substantially equivalent to K952705 (Spirit Ridge Technologies, 1995) after an 86-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jul 18, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- FZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952705 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952705 Spirit Ridge Nasal ImplantSpirit Ridge Technologies · 1995
- This deviceK971481 Duralastic Anatomical Nasal ImplantsAllied Biomedical Corp. · 1997
- Descendant · cites it directly · 1 of its ownK973573 Duralastic Anatomical Nasal ImplantsHanson Medical, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK090803 Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952705 | Spirit Ridge Nasal Implant | Spirit Ridge Technologies | 1995 | — |
| 0 (this device) | K971481 | Duralastic Anatomical Nasal Implants | Allied Biomedical Corp. | 1997 | — |
| +1 | K973573 | Duralastic Anatomical Nasal Implants | Hanson Medical, Inc. | 1997 | — |
| +2 | K090803 | Hanson Medical Facial Implants | Hanson Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K952705 | Spirit Ridge Nasal Implant Our OCR of the scanned summary read “K952705” beside “510(k)”; FDA’s K952705 is the only number that fits it and carries the summary’s name for the device. Summary page 1…e and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants. SUBSTANTIAL EQUIVALENCE Under it original 510(k) K952705, Duralastic Nasal implants were found SE to the Applied Biomedical nasal implants. In fact the very same molds and materials are… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973573 | Duralastic Anatomical Nasal Implants | 1997 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K973573 (Hanson Medical, Inc., 1997) has gone furthest, with 1 descendant 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?
The Duralastic Anatomical Nasal Implants are intended to be used to augment or reconstruct the nasal bridge and nasal profile for cosmetic or reconstructive surgery.
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/K971481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971481: 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/K971481
Report an extraction error
Are you the manufacturer?
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