510(k) · Cleared
ClearedPacific Surgical Patties
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
V. Mueller Neuro/Spine · HBA Neurosurgical Paddie
Cleared on Mar 30, 2000 after a 204-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 30, 2000
- Review
- 204 days
- Class
- Class II
- Product code
- HBA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK993019 Pacific Surgical PattiesV. Mueller Neuro/Spine · 2000
- Descendant · cites it directly · 1 of its ownK031008 Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)Aesculap · 2003
- Descendant · 2 generations on · 0 of its ownK062406 Aesculap Neuro PattiesAesculap, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK014268 Norapad Plain; Norapad TAPerlei Medical, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993019 | Pacific Surgical Patties | V. Mueller Neuro/Spine | 2000 | — |
| +1 | K031008 | Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White) | Aesculap | 2003 | — |
| +2 | K062406 | Aesculap Neuro Patties | Aesculap, Inc. | 2006 | — |
| +1 | K014268 | Norapad Plain; Norapad TA | Perlei Medical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | — | Codman Surgical Patties Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K031008 (Aesculap, 2003) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
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/K993019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993019: Pacific Surgical Patties.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993019
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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