510(k) · Cleared

Cleared

Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U Filter, Extension Set with Microbore

K974013510(k) TraditionalCleared Dec 17, 199756-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

Sims Deltec, Inc. · FPA Set, Administration, Intravascular

Cleared on Dec 17, 1997 as substantially equivalent to K942046 (Pharmacia Deltec, Inc., 1994) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1981. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Dec 17, 1997
Review: 56 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K811463 (1981). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK811463 Auto-Syringe Micro Volume Extension SetBaxter Healthcare Corp · 1981 · Recalled
This deviceK974013 Extension Set with Microbore Tubing, Extension Set with Microbore…Sims Deltec, Inc. · 1997
Descendant · cites it directly · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021

Class I recalls in this family

K162219 CADD® Infusion Disposables Portfolio with NRFit™…cites it directly · 2017

Most influential descendants

Showing 2 of 2 · See all

K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · cites it directly1descendant
K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K811463	Auto-Syringe Micro Volume Extension Set	Baxter Healthcare Corp	1981	4
0 (this device)	K974013	Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and…	Sims Deltec, Inc.	1997	—
+1	K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors	Smiths Medical Asd, Inc.	2017	Class I
+2	K211649	PCEA Syringe Set	Baxter Healthcare Corporation	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	1
2021	1	0

FIG. 1 — Lineage of K974013, 1981–2021Source: 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.

1 device in this family has a Class I recall. 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? (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
*	K942046	Pharmacia Deltec Extension Set with Anti-Siphon Valve Summary page 2 …Micro-Velume microbore tubing micrebore tubing and microbore tubing, 0.2 anti-siphon valve Extension Set with 0.2 u filter 1 filter, and anti- 022 p Filter siphon valve K942046 K811463 MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. Baxter Healthcare Corporation INTEND…	Pharmacia Deltec, Inc.	1994	—
*	K811463	Auto-Syringe Micro Volume Extension Set Summary page 2 …elume microbore tubing micrebore tubing and microbore tubing, 0.2 anti-siphon valve Extension Set with 0.2 u filter 1 filter, and anti- 022 p Filter siphon valve K942046 K811463 MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. Baxter Healthcare Corporation INTENDED USE T…	Baxter Healthcare Corp	1981	4

Also cleared against K942046: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors Class I	Smiths Medical Asd, Inc.	2017	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K162219 (Smiths Medical Asd, Inc., 2017) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K942046.

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?

The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps.

The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.

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/K974013 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974013: Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U Filter, Extension Set with Microbore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974013

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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