510(k) · Cleared

Cleared

Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)

K031008510(k) TraditionalCleared May 9, 200339-day reviewClass II21 CFR 882.4700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap · HBA Neurosurgical Paddie

Cleared on May 9, 2003 as substantially equivalent to K880402 (Codman & Shurtleff, Inc., 1988) and 1 other predicate after a 39-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided: May 9, 2003
Review: 39 days
Class: Class II
Product code: HBA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K880402 (1988). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK880402 Codman Surgical PattieCodman & Shurtleff, Inc. · 1988 · Recalled
This deviceK031008 Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)Aesculap · 2003
Descendant · cites it directly · 0 of its ownK062406 Aesculap Neuro PattiesAesculap, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K062406Aesculap Neuro PattiesAesculap, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K880402	Codman Surgical Pattie	Codman & Shurtleff, Inc.	1988	3
0 (this device)	K031008	Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)	Aesculap	2003	—
+1	K062406	Aesculap Neuro Patties	Aesculap, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K031008, 1988–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K880402	Codman Surgical Pattie Our reading of the summary gave K889402, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman Surgical Pattie”.	Codman & Shurtleff, Inc.	1988	3
*	K993019	Pacific Surgical Patties Summary page 1 …ed in this premarket notification are substantially equivalent to these predicate devices: . Codman Surgical Pattie (K889402) . Pacific Surgical Patties (K993019) [ DEPARTMENT OF HEALTH & HUMAN SERVICES…	V. Mueller Neuro/Spine	2000	—

Also cleared against K880402: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062406	Aesculap Neuro Patties	Aesculap, Inc.	2006	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K062406 (Aesculap, Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K880402.

How does its category compare?

All HBA devices

HBA Neurosurgical Paddie: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBA

1in 2020

2007high 1 (2008) · low 0 (2007)2026

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

2007high 23 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBA

5in 2025

2007high 58 (2018) · low 5 (2025)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/K031008 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031008: Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031008

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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