510(k) Report

510(k) · Cleared

Cleared

Safetynet Guidewire Introducer

K040029510(k) TraditionalCleared Apr 5, 200488-day reviewClass II21 CFR 870.1340

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

Injectimed, Inc. · DYB Introducer, Catheter

Cleared on Apr 5, 2004 as substantially equivalent to K843719 (Ocean Medical Products, Ltd., 1984) and 5 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.

Decided
Apr 5, 2004
Review
88 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K971165 (1997). 7 ancestors in all, the oldest K843719 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2008: 1 descendant clearedK971165 · Introducer Sheath and Dilator · Boston Scientific Corp · 1997×2: 2 generations cleared close together, K020563 (2002), K022689 (2002) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K022689 · Modification to Medamicus Axia RSN · Medamicus, Inc. · 2002K020563 · Medamicus Axia RSN · Medamicus, Inc. · 2002K971165 · Introducer Sheath and Dilator · Boston Scientific Corp · 19970
  1. Root · 3 generations backK971165 Introducer Sheath and DilatorBoston Scientific Corp · 1997
  2. 2 generations backK020563 Medamicus Axia RSNMedamicus, Inc. · 2002
  3. 1 generation backK022689 Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
  4. This deviceK040029 Safetynet Guidewire IntroducerInjectimed, Inc. · 2004
  5. Descendant · cites it directly · 0 of its ownK073664 Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K971165Introducer Sheath and DilatorBoston Scientific Corp1997—
−2K020563Medamicus Axia RSNMedamicus, Inc.2002—
−1K022689Modification to Medamicus Axia RSNMedamicus, Inc.2002—
0 (this device)K040029Safetynet Guidewire IntroducerInjectimed, Inc.2004—
+1K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K040029, 1997–2008Source: 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 DYB? 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 DYB device

  1. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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
*K843719Single Wall Introducer Needle
Summary page 1
…ve been promulgated under Section 514 Predicate Devices · Hart Enterprises Single Wall Introducer Needle (K843719) * Manan Manufacturing Co. GWI Guide Wire Introducer (K851834) * Needletech, Inc. Guidewire Introduce…
Ocean Medical Products, Ltd.1984—
*K851834Manan Gwi Guide Wire Introducer
Summary page 1
…tion 514 Predicate Devices · Hart Enterprises Single Wall Introducer Needle (K843719) * Manan Manufacturing Co. GWI Guide Wire Introducer (K851834) * Needletech, Inc. Guidewire Introducer Needle (K031173) * Medamicus Axia RSN TM Guidewire Introduce…
Manan Manufacturing Co., Inc.1985—
*K031173Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013
Summary page 1
…all Introducer Needle (K843719) * Manan Manufacturing Co. GWI Guide Wire Introducer (K851834) * Needletech, Inc. Guidewire Introducer Needle (K031173) * Medamicus Axia RSN TM Guidewire Introducer Safety Needle (K011085, K020563 and K022689) Intend…
Needle Tech Products, Inc.2003—
*K011085Guidewire Introducer Safety Needle
Summary page 1
…K851834) * Needletech, Inc. Guidewire Introducer Needle (K031173) * Medamicus Axia RSN TM Guidewire Introducer Safety Needle (K011085, K020563 and K022689) Intended Use The Frontline Medical Products SafetyNet TM Guidewire Introducer is intended for single u…
Medamicus, Inc.2001—
*K020563Medamicus Axia RSN
Summary page 1
…* Needletech, Inc. Guidewire Introducer Needle (K031173) * Medamicus Axia RSN TM Guidewire Introducer Safety Needle (K011085, K020563 and K022689) Intended Use The Frontline Medical Products SafetyNet TM Guidewire Introducer is intended for single use, for p…
Medamicus, Inc.2002—
*K022689Modification to Medamicus Axia RSN
Summary page 1
…Needletech, Inc. Guidewire Introducer Needle (K031173) * Medamicus Axia RSN TM Guidewire Introducer Safety Needle (K011085, K020563 and K022689) Intended Use The Frontline Medical Products SafetyNet TM Guidewire Introducer is intended for single use, for percutaneous…
Medamicus, Inc.2002—

Also cleared against K843719: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc.20080

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 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K073664 (Injectimed, Inc., 2008) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K843719.

How does its category compare?

All DYB devices

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

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Frontline Medical Products SafetyNet TM Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.

Indications for use as stated in the FDA summary.

Also cleared against K843719

2 other devices cite the same predicate.

  • K030451Carbon Medical Technologies Injection NeedleCarbon Medical Technologies, Inc. · 2003
  • K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998

More from Injectimed, Inc.

3 FDA decisions under this applicant name. See the company

  • K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008
  • K922158Protector Syringe Safety Cap SystemInjectimed, Inc. · 1992

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K040029 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040029: Safetynet Guidewire Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040029

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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