510(k) · Cleared

Cleared

Spectra Guidewire Introducer Needle

K082580510(k) TraditionalCleared Dec 8, 200894-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

Spectra Medical Devices, Inc. · DYB Introducer, Catheter

Cleared on Dec 8, 2008 as substantially equivalent to K851140 (Teleflexmedical, Inc., 1985) after a 94-day review. Its family tree reaches back 1 generation to 1985.

Decided: Dec 8, 2008
Review: 94 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K851140 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK851140 Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 1985
This deviceK082580 Spectra Guidewire Introducer NeedleSpectra Medical Devices, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851140	Teleflex Medical Introducer Needle	Teleflexmedical, Inc.	1985	—
0 (this device)	K082580	Spectra Guidewire Introducer Needle	Spectra Medical Devices, Inc.	2008	—

FIG. 1 — Lineage of K082580, 1985–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K851140	Teleflex Medical Introducer Needle Summary page 1 …e and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices Teleflex Medical Introducer Needle (K851140), and Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040). SPECTRA…	Teleflexmedical, Inc.	1985	—
*	—	Cook Percutaneous Entry Needle (Pre-amendment device) Named without a submission number			—

Also cleared against K851140: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
3 other devices also cite its predicate K851140.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082580 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082580: Spectra Guidewire 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/K082580

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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