510(k) Report

510(k) · Cleared

Cleared

Arrow-Fischell Extended Vascular Access Needle

K924338510(k) TraditionalCleared Mar 18, 1993203-day reviewClass II21 CFR 870.1390

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

Arrow Intl., Inc. · DRC Trocar

Cleared on Mar 18, 1993 after a 203-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Mar 18, 1993
Review
203 days
Class
Class II
Product code
DRC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceK924338 Arrow-Fischell Extended Vascular Access NeedleArrow Intl., Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK071998 Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 2007 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924338Arrow-Fischell Extended Vascular Access NeedleArrow Intl., Inc.1993—
+1K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc.20072

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K924338, 1993–2007Source: 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 DRC? 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 DRC device

  1. #1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc.20070

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?

  • Of its descendants, K071998 (Arrow Intl., Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRC devices

DRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRC

2in 2024

2007: 12008: 12011: 12012: 12013: 12014: 22017: 22018: 22021: 12022: 22024: 2
2007high 2 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRC

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

Recalls per year · DRC

1in 2021

2009: 12010: 12013: 12014: 12019: 1, 1 Class I2021: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DRC

69in 2025

2007: 1062008: 22009: 172010: 332011: 682012: 582013: 372014: 652015: 522016: 622017: 702018: 852019: 952020: 1082021: 782022: 612023: 1092024: 1052025: 69
2007high 109 (2023) · low 2 (2008)2025

MAUDE reports naming product code DRC, 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
20071—0106
20081—02
20090—117
20100—133
20111—068
20121—058
20131—137
20142—165
20150—052
20160—062
20172—070
20182—085
20190—1 (1)95
20200—0108
20211—178
20222—061
20230—0109
20242—0105
20250—069
20260—0—

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 DRC

The DRC category page

  • K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical Corporation · 2024
  • K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC · 2024
  • K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC · 2022
  • K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd. · 2022
  • K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC · 2021

https://510kreport.com/device/K924338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924338: Arrow-Fischell Extended Vascular Access Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924338

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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