510(k) · Cleared
ClearedNeurosurgical Sponges and Paddles and Neuro Patties and Neurosponges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harod Enterprises, Inc. · HBA Neurosurgical Paddie
Cleared on Feb 22, 2008 as substantially equivalent to K935883 (Mcneil Healthcare, Inc., 1994) after a 65-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 22, 2008
- Review
- 65 days
- Class
- Class II
- Product code
- HBA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935883 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK935883 Neurological SpongesMcneil Healthcare, Inc. · 1994
- This deviceK073576 Neurosurgical Sponges and Paddles and Neuro Patties and NeurospongesHarod Enterprises, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935883 | Neurological Sponges | Mcneil Healthcare, Inc. | 1994 | — |
| 0 (this device) | K073576 | Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges | Harod Enterprises, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K935883 | Neurological SpongesSummary page 1…HE, Inc.'s device has the same intended use and identical technological characteristics as the predicate Neurological Sponges made by McNeil Healthcare, Inc. under K935883 and product codes 20501, 20502, 20504, 20505, 20506, and 20507. A copy of the letter from McNeil Healthcare authorizing th… | 1994 |
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. 2008, 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 neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073576: Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073576
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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