510(k) Report

510(k) · Cleared

Cleared

P.D. Access (Percutaneous Doppler) Vascular Access Device

K963989510(k) TraditionalCleared Apr 24, 1997202-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 Apr 24, 1997 as substantially equivalent to K903625 (Peripheral Systems Group, 1990) and 4 other predicates after a 202-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.

Decided
Apr 24, 1997
Review
202 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K851141 (1985). 5 ancestors in all. 2 later devices descend 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 ancestor1998: 1 descendant cleared2009: 1 descendant clearedK851141 · Teleflex Medical Introducer Catheter · Teleflexmedical, Inc. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K851141 · Teleflex Medical Introducer Catheter · Teleflexmedical, Inc. · 19850
  1. Root · 1 generation backK851141 Teleflex Medical Introducer CatheterTeleflexmedical, Inc. · 1985
  2. This deviceK963989 P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK973713 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle…Cardiovascular Dynamics, Inc. · 1998
  4. Descendant · 2 generations on · 0 of its ownK090743 Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…Cardiovascular Dynamics, Inc. · 1998 · cites it directly1descendant
  • K090743Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851141Teleflex Medical Introducer CatheterTeleflexmedical, Inc.1985—
0 (this device)K963989P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc.1997—
+1K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24…Cardiovascular Dynamics, Inc.1998—
+2K090743Yield 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
199810
200910
FIG. 1 — Lineage of K963989, 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K903625Doppler Needle and Flow Monitor
Summary page 1
…ichael Crocker September 18, 1996 P.D. Access™ Vascular Access Device SmartNeedle® Vascular Access Device ) ‘Ultrasonic Blood Flow Monitor CVD 18 gauge SmartNeedle® K903625 SE Date: November 7, 1990 CvD 18 gauge SmartNeedle® K913746/A SE Date: December 17, 1991 CvD 20 gauge SmartfNeedie® K913941…
Peripheral Systems Group19901
*K913746Smartneedle (TM) Vascular Access System
Summary page 1
…s Device SmartNeedle® Vascular Access Device ) ‘Ultrasonic Blood Flow Monitor CVD 18 gauge SmartNeedle® K903625 SE Date: November 7, 1990 CvD 18 gauge SmartNeedle® K913746/A SE Date: December 17, 1991 CvD 20 gauge SmartfNeedie® K913941/A SE Date: February 27, 1992 CvD 20 gauge SmartNeedle® K940…
Peripheral Systems Group1991—
*K913941PSG (TM) 20 Guage Doppler Needle
Summary page 1
…low Monitor CVD 18 gauge SmartNeedle® K903625 SE Date: November 7, 1990 CvD 18 gauge SmartNeedle® K913746/A SE Date: December 17, 1991 CvD 20 gauge SmartfNeedie® K913941/A SE Date: February 27, 1992 CvD 20 gauge SmartNeedle® K940804 SE Date: June 10, 1994 TFX Medical Over the Needle Splittable…
Peripheral Systems Group1992—
*K940804Smartneedle Vascular Access System, Modification
Summary page 1
…7, 1990 CvD 18 gauge SmartNeedle® K913746/A SE Date: December 17, 1991 CvD 20 gauge SmartfNeedie® K913941/A SE Date: February 27, 1992 CvD 20 gauge SmartNeedle® K940804 SE Date: June 10, 1994 TFX Medical Over the Needle Splittable Catheter K920208 TFX Medical Introducer Catheter K851141 The P.…
Peripheral Systems Group1994—
Kept off the family treeK920208FDA’s K920208 is Urine a Calibrator
Our OCR of the scanned summary read K920208, FDA’s number for Urine a Calibrator (Diagnostic Reagents, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Over the Needle Splittable Catheter”. Kept off the family tree.
Summary page 1
…20 gauge SmartfNeedie® K913941/A SE Date: February 27, 1992 CvD 20 gauge SmartNeedle® K940804 SE Date: June 10, 1994 TFX Medical Over the Needle Splittable Catheter K920208 TFX Medical Introducer Catheter K851141 The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the S…
Diagnostic Reagents, Inc.1992—
*K851141Teleflex Medical Introducer Catheter
Summary page 1
…: February 27, 1992 CvD 20 gauge SmartNeedle® K940804 SE Date: June 10, 1994 TFX Medical Over the Needle Splittable Catheter K920208 TFX Medical Introducer Catheter K851141 The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmartNeedle® Monitor for general vascular…
Teleflexmedical, Inc.1985—

Also cleared against K903625: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…Cardiovascular Dynamics, Inc.19981

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K973713 (Cardiovascular Dynamics, Inc., 1998) has gone furthest, with 1 descendant 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?

The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature.

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.

  • K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access…Cardiovascular Dynamics, Inc. · 1998

More from Cardiovascular Dynamics, Inc.

11 FDA decisions under this applicant name. See the company

  • K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access…Cardiovascular Dynamics, Inc. · 1998
  • K971577Focus-PV Balloon Dilatation CatheterCardiovascular 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/K963989 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963989

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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