510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Percutaneous Sheath Introducer Kit

K780532510(k) TraditionalCleared Apr 21, 197817-day reviewClass II21 CFR 870.1340Recalls 17 (1 Class I)

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

Arrow Intl., Inc. · DYB Introducer, Catheter

Cleared on Apr 21, 1978 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 17 times, including a Class I recall.

Decided
Apr 21, 1978
Review
17 days
Class
Class II
Product code
DYB
Recalls
17 (1 Class I)
Predicates
0

3 later devices descend from it, 3 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2020: 1 descendant cleared2011: 1 descendant cleared19801990200020102020
  1. This deviceK780532 Percutaneous Sheath Introducer KitArrow Intl., Inc. · 1978
  2. Descendant · cites it directly · 0 of its ownK202330 Impella XR Sheath SetAbiomed, Inc. · 2020
  3. Descendant · cites it directly · 0 of its ownK112554 Transradial Artery Access DevicesTeleflexmedical, Inc. · 2011 · Recalled
  4. Descendant · cites it directly · 0 of its ownK021723 Sheath Adapter, Model SA-09847Arrow Intl., Inc. · 2002 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K202330Impella XR Sheath SetAbiomed, Inc. · 2020 · cites it directly0descendants
  • K112554Transradial Artery Access DevicesTeleflexmedical, Inc. · 2011 · cites it directly0descendants
  • K021723Sheath Adapter, Model SA-09847Arrow Intl., Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K780532Percutaneous Sheath Introducer KitArrow Intl., Inc.1978—
+1K202330Impella XR Sheath SetAbiomed, Inc.2020—
+1K112554Transradial Artery Access DevicesTeleflexmedical, Inc.20111
+1K021723Sheath Adapter, Model SA-09847Arrow Intl., Inc.20021

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201110
202010
FIG. 1 — Lineage of K780532, 1978–2020Source: 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.

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.

Top candidate predicates for a new DYB device

  1. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202330Impella XR Sheath SetAbiomed, Inc.20200
K112554Transradial Artery Access DevicesTeleflexmedical, Inc.20110
K021723Sheath Adapter, Model SA-09847Arrow Intl., Inc.20020

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 21, 2026Class IZ-2385-2026Nonconforming Material/ComponentLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a…
Dec 20, 2019Class IIZ-1242-2020Incorrect or no expiration dateProduct lidstock contains the incorrect expiration date for the product
May 23, 2018Class IIZ-2576-2018Process controlProduct contains dry natural rubber latex. Label states Latex Free.
Apr 11, 2018Class IIZ-2031-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Apr 11, 2018Class IIZ-1977-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Apr 11, 2018Class IIZ-1976-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Apr 11, 2018Class IIZ-2011-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Apr 11, 2018Class IIZ-2032-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.
Dec 22, 2017Class IIZ-1329-2018Process controlCertain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Nov 14, 2017Class IIZ-1158-2018Labeling mix-upsProducts do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Oct 26, 2017Class IIZ-1287-2018Nonconforming Material/ComponentThe povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
May 9, 2017Class IIZ-2329-2017PackagingArrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Aug 6, 2014Class IIZ-0066-2015PackagingThe component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.
Apr 14, 2014Class IIZ-1713-2014Process controlArrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
Oct 9, 2013Class IIZ-0468-2014Process controlThere is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
Mar 25, 2011Not classifiedZ-2048-2011OtherLabeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.
Dec 20, 2010Not classifiedZ-0936-2011OtherPackaging may have been compromised, and sterility of product cannot be guaranteed.

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K202330 (Abiomed, Inc., 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

More from Arrow Intl., Inc.

110 FDA decisions under this applicant name. See the company

  • K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002…Arrow Intl., Inc. · 2010
  • K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
  • K071491Arrow International, Inc., Surgical DrapesArrow Intl., Inc. · 2007
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 20072 recalls
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K780532 · printed Nov 4, 2026

Cite this page

510(k) Report. “K780532: Percutaneous Sheath Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K780532

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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