510(k) Report

510(k) · Cleared

Cleared

Siterite Needle Guide (Modified)

K931403510(k) TraditionalCleared Jul 27, 1993130-day reviewClass II21 CFR 870.1250

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

Dymax Corp · DQY Catheter, Percutaneous

Cleared on Jul 27, 1993 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided
Jul 27, 1993
Review
130 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

18 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2004: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2009: 1 descendant cleared2016: 1 descendant cleared2015: 2 descendants cleared2025: 4 descendants cleared2018: 1 descendant cleared2026: 2 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK931403 Siterite Needle Guide (Modified)Dymax Corp · 1993
  2. Descendant · cites it directly · 12 of its ownK042445 Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc. · 2004
  3. Descendant · 2 generations on · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
  4. Descendant · 3 generations on · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
  5. Descendant · 4 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
  6. Descendant · cites it directly · 4 of its ownK043425 Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various…Sheathing Technologies, Inc. · 2005

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12009: 12012: 12015: 22016: 12017: 12018: 12021: 12023: 12024: 12025: 42026: 2
2004high 4 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 18 · See all
  • K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc. · 2004 · cites it directly12descendants
  • K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012 · 2 generations on8descendants
  • K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · 3 generations on6descendants
  • K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 4 generations on4descendants
  • K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based…Sheathing Technologies, Inc. · 2005 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931403Siterite Needle Guide (Modified)Dymax Corp1993—
+1K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc.2004—
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.2012—
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT…C.R. Bard, Inc.20151
+4K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT…C. R. Bard2018—
+1K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model…Sheathing Technologies, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200910
201210
201520
201610
201710
201810
202110
202310
202410
202540
202620
FIG. 1 — Lineage of K931403, 1993–2026Source: 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.

Planning a device in DQY? 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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc.200412
K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based…Sheathing Technologies, Inc.20054

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, K042445 (Bard Access Systems, Inc., 2004) has gone furthest, with 12 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 Dymax Corp

7 FDA decisions under this applicant name. See the company

  • K032135Site-Rite IV Ultrasound SystemDymax Corp · 2003
  • K993624Site-Rite 3 Ultrasound SystemDymax Corp · 1999
  • K903158Siterite Needle GuideDymax Corp · 1990
  • K894415Dymax Endovaginal Biopsy GuideDymax Corp · 1989
  • K862127Dymax Personal ScannerDymax Corp · 1986

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https://510kreport.com/device/K931403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931403: Siterite Needle Guide (Modified).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931403

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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