510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Polyester Sponge Pattie

K862494510(k) TraditionalCleared Jul 30, 198629-day reviewClass II21 CFR 882.4700Recalls 4

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

American Silk Sutures, Inc. · HBA Neurosurgical Paddie

Cleared on Jul 30, 1986 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 4 times.

Decided
Jul 30, 1986
Review
29 days
Class
Class II
Product code
HBA
Recalls
4
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1990200020102020
  1. This deviceK862494 Polyester Sponge PattieAmerican Silk Sutures, Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK121822 DelicotAmerican Surgical Company, LLC · 2012 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K121822DelicotAmerican Surgical Company, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862494Polyester Sponge PattieAmerican Silk Sutures, Inc.1986—
+1K121822DelicotAmerican Surgical Company, LLC201221

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K862494, 1986–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K193346 Codman Surgical Patties & Stripsscore -1.6 · 1 generation · no Class I recall
Get a 510(k) Report

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? (1)

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

NumberDeviceApplicantDecidedDescendants
K121822DelicotAmerican Surgical Company, LLC20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2016Class IIZ-1810-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1808-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1807-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1809-2016Packaging process controlProduct packaging defective compromising sterility

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K121822 (American Surgical Company, LLC, 2012) has gone furthest, with 0 descendants of its own.

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

2008: 12012: 12013: 12014: 12020: 1
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

2010: 32022: 12024: 232026 (partial year): 2
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

2007: 122008: 202009: 142010: 252011: 172012: 132013: 192014: 432015: 382016: 402017: 352018: 582019: 572020: 312021: 442022: 282023: 292024: 272025: 5
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—012
20081—020
20090—014
20100—325
20110—017
20121—013
20131—019
20141—043
20150—038
20160—040
20170—035
20180—058
20190—057
20201—031
20210—044
20220—128
20230—029
20240—2327
20250—05
20260—2—

More from American Silk Sutures, Inc.

14 FDA decisions under this applicant name. See the company

  • K922143American Burn SheetAmerican Silk Sutures, Inc. · 1992
  • K904514Strung Telfa Non-Adherent SpongeAmerican Silk Sutures, Inc. · 19917 recalls
  • K902921Rayon Neurological SpongeAmerican Silk Sutures, Inc. · 199012 recalls
  • K872810Strung Dental RollsAmerican Silk Sutures, Inc. · 19871 recall
  • K872951American Brain Retractor CoverAmerican Silk Sutures, Inc. · 1987

Recent decisions in HBA

The HBA category page

  • K193346Codman Surgical Patties & StripsIntegra LifeSciences Corporation · 202023 recalls
  • K140369Medline Neuro SpongeMedline Industries, Inc. · 20142 recalls
  • K112598American Surgical Company/ Neurosurgical Sponges (Brand)American Surgical Company, LLC · 2013
  • K121822DelicotAmerican Surgical Company, LLC · 201221 recalls
  • K073576Neurosurgical Sponges and Paddles and Neuro Patties and NeurospongesHarod Enterprises, Inc. · 2008

https://510kreport.com/device/K862494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862494: Polyester Sponge Pattie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862494

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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