510(k) · Cleared
Recalled · Class II · 2016Rayon Neurological Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Silk Sutures, Inc. · HBA Neurosurgical Paddie
Cleared on Sep 18, 1990 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 12 times.
- Decided
- Sep 18, 1990
- Review
- 77 days
- Class
- Class II
- Product code
- HBA
- Recalls
- 12
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK902921 Rayon Neurological SpongeAmerican Silk Sutures, Inc. · 1990
- Descendant · cites it directly · 0 of its ownK121822 DelicotAmerican Surgical Company, LLC · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K121822DelicotAmerican Surgical Company, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902921 | Rayon Neurological Sponge | American Silk Sutures, Inc. | 1990 | — |
| +1 | K121822 | Delicot | American Surgical Company, LLC | 2012 | 21 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBA? 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 HBA device
- #1 K193346 Codman Surgical Patties & Stripsscore -1.6 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K121822 | Delicot | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2016 | Class II | Z-1795-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1770-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1771-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1798-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1796-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1772-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1794-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1768-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1767-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1774-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1765-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1797-2016 | Packaging process control | Product packaging defective compromising sterility |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121822 (American Surgical Company, LLC, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HBA devicesHBA Neurosurgical Paddie: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HBA
Too few HBA 510(k)s in any year since 2007 to give a median.
Recalls per year · HBA
23in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBA
5in 2025
MAUDE reports naming product code HBA, 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 | 0 | — | 0 | 12 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 3 | 25 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 1 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 40 |
| 2017 | 0 | — | 0 | 35 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 0 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 44 |
| 2022 | 0 | — | 1 | 28 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 23 | 27 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K902921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902921: Rayon Neurological Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902921
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026