510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Arrow-Johans Ecg Adaptor

K843263510(k) TraditionalCleared Sep 20, 198431-day reviewClass II21 CFR 870.1250Recalls 1

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

Arrow Intl., Inc. · DQY Catheter, Percutaneous

Cleared on Sep 20, 1984 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 37 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it. It has been recalled once.

Decided
Sep 20, 1984
Review
31 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
0

36 later devices descend from it, 2 citing it directly. 6 of the 37 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2010: 1 descendant cleared2014: 3 descendants cleared2011: 3 descendants cleared2015: 5 descendants cleared2012: 3 descendants cleared, 1 with a Class I recall12013: 4 descendants cleared, 2 with a Class I recall22017: 2 descendants cleared2021: 1 descendant cleared2016: 4 descendants cleared, 3 with a Class I recall32025: 4 descendants cleared2024: 1 descendant cleared2018: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK843263 Arrow-Johans Ecg AdaptorArrow Intl., Inc. · 1984
  2. Descendant · cites it directly · 34 of its ownK093775 Evguide Tip Location SystemRomedex International Srl · 2010
  3. Descendant · 2 generations on · 13 of its ownK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
  6. Descendant · 2 generations on · 7 of its ownK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1997: 12010: 12011: 32012: 32013: 42014: 32015: 52016: 42017: 22018: 22021: 12022: 12024: 12025: 42026: 1
1997high 5 (2015) · low 0 (1998)2026

Class I recalls in this family

  • K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet3 generations on · 2012
  • K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet3 generations on · 2013
  • K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet4 generations on · 2013
  • K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…4 generations on · 2016

Most influential descendants

Showing 5 of 36 · See all
  • K093775Evguide Tip Location SystemRomedex International Srl · 2010 · cites it directly34descendants
  • K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · 2 generations on13descendants
  • K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · 2 generations on10descendants
  • K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · 2 generations on8descendants
  • K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843263Arrow-Johans Ecg AdaptorArrow Intl., Inc.1984—
+1K093775Evguide Tip Location SystemRomedex International Srl2010—
+2K140799Celerity SysyemMedcomp (Medical Components, Inc.)20141
+2K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc.20114
+2K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc.20151
+2K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
201010
201130
201231
201342
201430
201550
201643
201720
201820
202110
202210
202410
202540
202610
FIG. 1 — Lineage of K843263, 1984–2026Source: 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.

6 devices in this family have 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K093775Evguide Tip Location SystemRomedex International Srl201034
K973371Certodyn Raecg Universal AdapterB.Braun Medical, Inc.19970

Has anything in its family been recalled? (6 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 11, 2018Class IIZ-2014-2018Under Investigation by firmProduct sterility may be compromised due to unsealed packaging.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
  • K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
  • K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • Of its descendants, K093775 (Romedex International Srl, 2010) has gone furthest, with 34 descendants of its own.

How does its category compare?

All DQY devices

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

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

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 DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K843263 · printed Nov 4, 2026

Cite this page

510(k) Report. “K843263: Arrow-Johans Ecg Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K843263

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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