510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

X-Ray Detectable Cotton Balls

K854714510(k) TraditionalCleared Dec 17, 198525-day reviewClass I21 CFR 878.4450Recalls 37

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. · GDY Gauze/Sponge, Internal, X-Ray Detectable

Cleared on Dec 17, 1985 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 37 times.

Decided
Dec 17, 1985
Review
25 days
Class
Class I
Product code
GDY
Recalls
37
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K854714Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 GDY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 18, 2024Class IIZ-0287-2025Process controlProduct defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
Mar 31, 2016Class IIZ-1735-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1731-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1732-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1748-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1736-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1727-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1738-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1747-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1759-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1754-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1729-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1746-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1737-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1757-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1758-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1750-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1728-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1743-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1734-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1745-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1742-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1755-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1740-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1756-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1744-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1730-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1749-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1762-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1752-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1733-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1741-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1724-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1723-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1760-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1753-2016Packaging process controlProduct packaging defective compromising sterility
Mar 31, 2016Class IIZ-1739-2016Packaging process controlProduct packaging defective compromising sterility

The 5 latest of 37 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GDY devices

GDY Gauze/Sponge, Internal, X-Ray Detectable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDY

FDA has decided no GDY device since 2007.

Median 510(k) review, days · GDY

Too few GDY 510(k)s in any year since 2007 to give a median.

Recalls per year · GDY

1in 2022

2008: 12010: 72012: 22015: 22017: 12018: 12019: 12022: 12026 (partial year): 1, 1 Class I
2007high 7 (2010) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GDY

112in 2025

2007: 152008: 252009: 962010: 442011: 382012: 802013: 402014: 652015: 1222016: 2912017: 2522018: 2502019: 1772020: 1162021: 1342022: 2262023: 982024: 1142025: 112
2007high 291 (2016) · low 15 (2007)2025

MAUDE reports naming product code GDY, 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—015
20080—125
20090—096
20100—744
20110—038
20120—280
20130—040
20140—065
20150—2122
20160—0291
20170—1252
20180—1250
20190—1177
20200—0116
20210—0134
20220—1226
20230—098
20240—0114
20250—0112
20260—1 (1)—

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 GDY

The GDY category page

  • K972634Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K960236CPR Lap SpongesCustom Pack Reliability · 1996
  • K955599Stryker Femoral Canal Sponge & Acetabulum SpongeStryker Corp. · 19965 recalls
  • K955322Protec X-Ray Detectable Gauze SpongeDerivados DE Gasa, S.A. DE C.V. · 1995
  • K953830KensorbKentron Health Care, Inc. · 1995

https://510kreport.com/device/K854714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854714: X-Ray Detectable Cotton Balls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854714

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026