510(k) · Cleared

Cleared

Teleflex Medical Introducer Needle

K851140510(k) TraditionalCleared Jun 19, 198590-day reviewClass I21 CFR 870.4500

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

Teleflexmedical, Inc. · DWS Instruments, Surgical, Cardiovascular

Cleared on Jun 19, 1985 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Jun 19, 1985
Review: 90 days
Class: Class I
Product code: DWS
Recalls: None
Predicates: 0

7 later devices descend from it, 4 citing it directly.

This deviceK851140 Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 1985
Descendant · cites it directly · 4 of its ownK021034 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
Descendant · cites it directly · 3 of its ownK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
Descendant · 2 generations on · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
Descendant · 2 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · See all

K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002 · cites it directly4descendants
K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004 · cites it directly3descendants
K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · 2 generations on1descendant
K211072Safety Trocar CannulaBoston Scientific Corporation · 2021 · 2 generations on0descendants
K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K851140	Teleflex Medical Introducer Needle	Teleflexmedical, Inc.	1985	—
+1	K021034	Modified TFX Medical Safety Needle with Introducer	Tfx Medical, Inc.	2002	—
+1	K043258	Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02	Teleflex Medical	2004	—
+2	K070449	Lumiloc (TM) Safety Introducer Needle	Specialized Health Products International, Inc.	2007	—
+2	K211072	Safety Trocar Cannula	Boston Scientific Corporation	2021	—
+2	K180725	Aspire Introducer Needle	Aspire Bariatrics, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	1	0
2007	1	0
2008	1	0
2018	1	0
2021	1	0

FIG. 1 — Lineage of K851140, 1985–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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? (7)

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

Number	Device	Applicant	Decided	Descendants
K021034	Modified TFX Medical Safety Needle with Introducer	Tfx Medical, Inc.	2002	4
K043258	Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02	Teleflex Medical	2004	3
K082580	Spectra Guidewire Introducer Needle	Spectra Medical Devices, Inc.	2008	0
K020985	Modified TFX Medical Safety Needle with Introducer	Tfx Medical, Inc.	2002	0

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, K021034 (Tfx Medical, Inc., 2002) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DWS devices

DWS Instruments, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWS

FDA has decided no DWS device since 2007.

Median 510(k) review, days · DWS

Too few DWS 510(k)s in any year since 2007 to give a median.

Recalls per year · DWS

1in 2022

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWS

12in 2025

2007high 60 (2018) · low 12 (2025)2025

MAUDE reports naming product code DWS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	20
2008	—	0	15
2009	—	0	44
2010	—	1	27
2011	—	1	55
2012	—	0	33
2013	—	0	34
2014	—	0	43
2015	—	0	26
2016	—	1	33
2017	—	0	40
2018	—	0	60
2019	—	0	28
2020	—	0	28
2021	—	0	32
2022	—	1	35
2023	—	0	18
2024	—	0	48
2025	—	0	12
2026	—	0	—

https://510kreport.com/device/K851140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K851140: Teleflex Medical Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851140

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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