510(k) · Cleared

Cleared

Single Wall Introducer Needle

K843719510(k) TraditionalCleared Oct 18, 198424-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

Ocean Medical Products, Ltd. · DYB Introducer, Catheter

Cleared on Oct 18, 1984 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided: Oct 18, 1984
Review: 24 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 0

24 later devices descend from it, 3 citing it directly.

This deviceK843719 Single Wall Introducer NeedleOcean Medical Products, Ltd. · 1984
Descendant · cites it directly · 20 of its ownK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
Descendant · 2 generations on · 13 of its ownK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
Descendant · 2 generations on · 12 of its ownK022484 Cook Injection NeedleCook Urological, Inc. · 2002
Descendant · 3 generations on · 3 of its ownK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · Recalled
Descendant · 2 generations on · 3 of its ownK051905 Uroplasty Rigid Endoscopic NeedleUroplasty, Inc. · 2005

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1998high 3 (2009) · low 0 (2000)2026

Most influential descendants

Showing 5 of 24 · See all

K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998 · cites it directly20descendants
K990996Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999 · 2 generations on13descendants
K022484Cook Injection NeedleCook Urological, Inc. · 2002 · 2 generations on12descendants
K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · 3 generations on3descendants
K051905Uroplasty Rigid Endoscopic NeedleUroplasty, Inc. · 2005 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K843719	Single Wall Introducer Needle	Ocean Medical Products, Ltd.	1984	—
+1	K982890	Advanced Uroscience Injection Needle	Advanced Uroscience, Inc.	1998	—
+2	K990996	Genyx Medical Injection Needle	Genyx Medical, Inc.	1999	—
+2	K022484	Cook Injection Needle	Cook Urological, Inc.	2002	—
+3	K090830	Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip	Laborie Medical Technologies, Ltd.	2009	1
+2	K051905	Uroplasty Rigid Endoscopic Needle	Uroplasty, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2008	2	0
2009	3	0
2012	2	0
2014	1	0
2017	2	0
2018	1	0
2019	1	0
2020	1	0
2022	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K843719, 1984–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K982890	Advanced Uroscience Injection Needle	Advanced Uroscience, Inc.	1998	20
K040029	Safetynet Guidewire Introducer	Injectimed, Inc.	2004	1
K030451	Carbon Medical Technologies Injection Needle	Carbon Medical Technologies, Inc.	2003	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, K982890 (Advanced Uroscience, Inc., 1998) has gone furthest, with 20 descendants of its own.

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

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)	—

https://510kreport.com/device/K843719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843719: Single Wall 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/K843719

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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