510(k) · Cleared
Recalled · 2010Codman Surgical Pattie
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HBA Neurosurgical Paddie
Cleared on Mar 2, 1988 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 2, 1988
- Review
- 33 days
- Class
- Class II
- Product code
- HBA
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK880402 Codman Surgical PattieCodman & Shurtleff, Inc. · 1988
- Descendant · cites it directly · 1 of its ownK031008 Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)Aesculap · 2003
- Descendant · cites it directly · 0 of its ownK193346 Codman Surgical Patties & StripsIntegra LifeSciences Corporation · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK062406 Aesculap Neuro PattiesAesculap, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K031008Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)Aesculap · 2003 · cites it directly1descendant
- K193346Codman Surgical Patties & StripsIntegra LifeSciences Corporation · 2020 · cites it directly0descendants
- K062406Aesculap Neuro PattiesAesculap, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880402 | Codman Surgical Pattie | Codman & Shurtleff, Inc. | 1988 | — |
| +1 | K031008 | Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White) | Aesculap | 2003 | — |
| +1 | K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | 2020 | 23 |
| +2 | K062406 | Aesculap Neuro Patties | Aesculap, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2020 | 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? (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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2010 | Not classified | Z-0094-2011 | Process control | Surgical Pattie x-ray stripe (radio-opaque marker) became detached |
| Jul 16, 2010 | Not classified | Z-0093-2011 | Process control | Surgical Pattie x-ray stripe (radio-opaque marker) became detached |
| Jul 16, 2010 | Not classified | Z-0095-2011 | Process control | Surgical Pattie x-ray stripe (radio-opaque marker) may become detached |
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 | — |
https://510kreport.com/device/K880402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K880402: Codman Surgical Pattie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880402
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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