510(k) Report

510(k) · Cleared

Cleared

22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car

K973713510(k) TraditionalCleared Jan 23, 1998116-day reviewClass II21 CFR 892.1570

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

Cardiovascular Dynamics, Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Jan 23, 1998 as substantially equivalent to K903625 (Peripheral Systems Group, 1990) and 5 other predicates after a 116-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.

Decided
Jan 23, 1998
Review
116 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K851141 (1985). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor2009: 1 descendant clearedK851141 · Teleflex Medical Introducer Catheter · Teleflexmedical, Inc. · 1985K963989 · P.D. Access (Percutaneous Doppler) Vascular Access Device · Cardiovascular Dynamics, Inc. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K963989 · P.D. Access (Percutaneous Doppler) Vascular Access Device · Cardiovascular Dynamics, Inc. · 1997K851141 · Teleflex Medical Introducer Catheter · Teleflexmedical, Inc. · 19850
  1. Root · 2 generations backK851141 Teleflex Medical Introducer CatheterTeleflexmedical, Inc. · 1985
  2. 1 generation backK963989 P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997
  3. This deviceK973713 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle…Cardiovascular Dynamics, Inc. · 1998
  4. Descendant · cites it directly · 0 of its ownK090743 Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K090743Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K851141Teleflex Medical Introducer CatheterTeleflexmedical, Inc.1985—
−1K963989P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc.1997—
0 (this device)K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24…Cardiovascular Dynamics, Inc.1998—
+1K090743Yield Mini Doppler SystemBroncus Technologies, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199210
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K973713, 1985–2009Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ITX? 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 ITX device

  1. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 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? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K903625Doppler Needle and Flow Monitor
Summary page 1
…ember 30, 1997 P.D. Access™ Percutaneous Doppler Vascular Access Device P.D. Access Dual Frequency Monitor Diagnostic Ultrasound Transducer CVD 18 gauge SmartNeedle® #K903625. SE Date: November 7, 1990 CVD 18 gauge SmartNeedle #K913746. SE Date: December 17, 1991 CVD 20 gauge SmartNeedle #K913941. SE…
Peripheral Systems Group19901
*K913746Smartneedle (TM) Vascular Access System
Summary page 1
…ess Device P.D. Access Dual Frequency Monitor Diagnostic Ultrasound Transducer CVD 18 gauge SmartNeedle® #K903625. SE Date: November 7, 1990 CVD 18 gauge SmartNeedle #K913746. SE Date: December 17, 1991 CVD 20 gauge SmartNeedle #K913941. SE Date: February 27, 1992 CVD 20 gauge SmartNeedle #K940804. SE…
Peripheral Systems Group1991—
*K913941PSG (TM) 20 Guage Doppler Needle
Summary page 1
…sound Transducer CVD 18 gauge SmartNeedle® #K903625. SE Date: November 7, 1990 CVD 18 gauge SmartNeedle #K913746. SE Date: December 17, 1991 CVD 20 gauge SmartNeedle #K913941. SE Date: February 27, 1992 CVD 20 gauge SmartNeedle #K940804. SE Date: June 10, 1994 CVD 22 gauge P.D. Access/SmartNeedle #K96…
Peripheral Systems Group1992—
*K940804Smartneedle Vascular Access System, Modification
Summary page 1
…November 7, 1990 CVD 18 gauge SmartNeedle #K913746. SE Date: December 17, 1991 CVD 20 gauge SmartNeedle #K913941. SE Date: February 27, 1992 CVD 20 gauge SmartNeedle #K940804. SE Date: June 10, 1994 CVD 22 gauge P.D. Access/SmartNeedle #K963989. SE Date: April 24, 1997 CVD 22 gauge P.D. Access/SmartNe…
Peripheral Systems Group1994—
*K963989P.D. Access (Percutaneous Doppler) Vascular Access Device
Summary page 1
…17, 1991 CVD 20 gauge SmartNeedle #K913941. SE Date: February 27, 1992 CVD 20 gauge SmartNeedle #K940804. SE Date: June 10, 1994 CVD 22 gauge P.D. Access/SmartNeedle #K963989. SE Date: April 24, 1997 CVD 22 gauge P.D. Access/SmartNeedle® #K963989. SE Date: April 24, 1997 TFX Medical Introducer Cathete…
Cardiovascular Dynamics, Inc.1997—
*K851141Teleflex Medical Introducer Catheter
Summary page 1
…auge P.D. Access/SmartNeedle #K963989. SE Date: April 24, 1997 CVD 22 gauge P.D. Access/SmartNeedle® #K963989. SE Date: April 24, 1997 TFX Medical Introducer Catheter #K851141 510(k) Notification CardioVascular Dynamics, Inc. September 30, 1997 P.D. Access™ Vascular Access Device P.D. A…
Teleflexmedical, Inc.1985—

Also cleared against K903625: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090743Yield Mini Doppler SystemBroncus Technologies, Inc.20090

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?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K090743 (Broncus Technologies, Inc., 2009) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K903625.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

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

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

What is it indicated for?

P.D. Access Device: is intended for use when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and introducer of this size or larger

These additional probe/needle models are being incorporated to broaden the product line in order to accommodate both user preference and patient anatomies for all age groups.

P.D. Access Monitor: Is intended for use to audibly indicate the doppler response of blood flow within an artery or vein. It is intended for use only in conjunction with the P.D. Access Vascular Access Device.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K903625

1 other device cites the same predicate.

  • K963989P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997

More from Cardiovascular Dynamics, Inc.

11 FDA decisions under this applicant name. See the company

  • K971577Focus-PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1997
  • K963989P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997
  • K963688Focus PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1997
  • K945693CVD Periflow (TM) (Small Vessel) Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1995
  • K952064Focus Balloon Dilatation CatheterCardiovascular Dynamics, Inc. · 1995

Recent decisions in ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K973713 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973713

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026