510(k) · Cleared

Cleared

Universal Vial Access Spike with Needleless Connector

K013949510(k) TraditionalCleared Mar 27, 2002117-day reviewClass II21 CFR 880.5440

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

Churchill Medical Systems, Inc. · FPA Set, Administration, Intravascular

Cleared on Mar 27, 2002 as substantially equivalent to K974363 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) after a 117-day review. Its family tree reaches back 3 generations to 1986.

Decided: Mar 27, 2002
Review: 117 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K854547 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK854547 Monoject Sterile M200 Aluminum/M250 PolypropyleneSherwood Medical Co. · 1986 · Recalled
2 generations backK964654 Becton Dickinson Blunt Plastic CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
1 generation backK974363 Becton Dickinson Blunt Plastic CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
This deviceK013949 Universal Vial Access Spike with Needleless ConnectorChurchill Medical Systems, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K854547	Monoject Sterile M200 Aluminum/M250 Polypropylene	Sherwood Medical Co.	1986	18
−2	K964654	Becton Dickinson Blunt Plastic Cannula	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	—
−1	K974363	Becton Dickinson Blunt Plastic Cannula	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	2
0 (this device)	K013949	Universal Vial Access Spike with Needleless Connector	Churchill Medical Systems, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K013949, 1986–2002Source: 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 FPA? 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (1)

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
*	K974363	Becton Dickinson Blunt Plastic Cannula Summary page 1 …versal Vial Access Spike with Needleless Connector IV Set Stopcock, IV Administration Set Accessories Class II, General Hospital 80 FPA B-D Blunt Plastic Cannula 510(k) 974363 The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetr…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	2

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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
3 of the 4 ancestors have a recall of any class.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

Churchill Medical Systems Vial Access Spike with Needleless Connector is used in L.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device eliminates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013949 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013949: Universal Vial Access Spike with Needleless Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013949

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026