510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Arterial Line Kit

K780871510(k) TraditionalCleared Jun 14, 197815-day reviewClass I21 CFR 878.4450Recalls 11 (1 Class I)

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

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

Cleared on Jun 14, 1978 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 11 times, including a Class I recall.

Decided
Jun 14, 1978
Review
15 days
Class
Class I
Product code
GDY
Recalls
11 (1 Class I)
Predicates
0

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

FIG. 1 — Lineage of K780871Source: 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.

1 device in this family has a Class I recall. 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? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 1, 2026Class IZ-2708-2026Material/Component ContaminationKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Jan 24, 2022Class IIZ-0563-2022Mixed-up of materials/componentsGuidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
Apr 8, 2020Class IIZ-1937-2020Under Investigation by firmArterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the…
Apr 8, 2020Class IIZ-1936-2020Under Investigation by firmArterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the…
Mar 29, 2010Not classifiedZ-1741-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010Not classifiedZ-1745-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010Not classifiedZ-1744-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010Not classifiedZ-1740-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010Not classifiedZ-1737-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010Not classifiedZ-1743-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010Not classifiedZ-1742-2010Package design/selectionThere are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

The 5 latest of 11 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 Argon Medical Corp.

27 FDA decisions under this applicant name. See the company

  • K904994Closed System Flush SetArgon Medical Corp. · 1991
  • K895511Catheter Balloon Dilator Pressure GaugeArgon Medical Corp. · 1990
  • K894157ObturatorArgon Medical Corp. · 1989
  • K891022Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
  • K884375Translumbar Aortography Needle CatheterArgon Medical Corp. · 1989

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/K780871 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780871: Arterial Line Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780871

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