510(k) · Cleared
ClearedAesculap Neuro Patties
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HBA Neurosurgical Paddie
Cleared on Sep 15, 2006 as substantially equivalent to K031008 (Aesculap, 2003) after a 29-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Sep 15, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- HBA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880402 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880402 | Codman Surgical Pattie | Codman & Shurtleff, Inc. | 1988 | 3 |
| −1 | K031008 | Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White) | Aesculap | 2003 | — |
| 0 (this device) | K062406 | Aesculap Neuro Patties | Aesculap, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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 |
|---|---|---|---|
| * | K031008 | Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)Summary page 1…84 HBA SUBSTANTIAL EQUIVALENCE Aesculap, Inc. believes that the Neurosorb Premium Patties are substantially equivalent to: Aesculap Neuro Patties (K031008) DEVICE DESCRIPTION Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general pr… | 2003 |
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 18 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
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 | — |
What is it indicated for?
Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue,
absorb fluids, or stop bleeding during neurological and other general procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062406: Aesculap Neuro Patties.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062406
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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