510(k) · Cleared
ClearedAmerican Surgical Company/ Neurosurgical Sponges (Brand)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Surgical Company, LLC · HBA Neurosurgical Paddie
Cleared on Jun 20, 2013 as substantially equivalent to K962807 (American Surgical Sponges, 1997) after a 652-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jun 20, 2013
- Review
- 652 days
- Class
- Class II
- Product code
- HBA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962807 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK962807 American Surgical Sponges/Neurosurgical SpongesAmerican Surgical Sponges · 1997
- This deviceK112598 American Surgical Company/ Neurosurgical Sponges (Brand)American Surgical Company, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962807 | American Surgical Sponges/Neurosurgical Sponges | American Surgical Sponges | 1997 | — |
| 0 (this device) | K112598 | American Surgical Company/ Neurosurgical Sponges (Brand) | American Surgical Company, LLC | 2013 | — |
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 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? (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 |
|---|---|---|---|
| * | K962807 | American Surgical Sponges/Neurosurgical SpongesSummary page 2…sification: Class II Current Legally Marketed ADevice: American Surgical Company Special 510(k) American Surgical Sponges (brand) Neurosurgical Sponges K962807 ~ Summary Description of the Device: The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and… | 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?
- Its one ancestor has no recall.
How does its category compare?
All HBA devicesHBA Neurosurgical Paddie: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.
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/K112598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112598: American Surgical Company/ Neurosurgical Sponges (Brand).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112598
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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