510(k) · Cleared

Cleared

Sapphire Administration Set

K141834510(k) SpecialCleared Aug 5, 201429-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

Q Core Medical, Ltd. · FPA Set, Administration, Intravascular

Cleared on Aug 5, 2014 as substantially equivalent to K123049 (Q Core Medical, Ltd., 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1990. 3 of the 17 devices in its family, counting itself, have a Class I recall.

Decided: Aug 5, 2014
Review: 29 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K904518 (1990). 16 ancestors in all. No later device cites it as a predicate yet. 3 of the 17 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
4 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
3 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
2 generations backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
1 generation backK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
This deviceK141834 Sapphire Administration SetQ Core Medical, Ltd. · 2014

Class I recalls in this family

K042121 Spectrum and Spectrum with Master Drug Library2 generations back · 2004
K011975 Horizon Outlook with Dosecom3 generations back · 2001
K994375 Horizon Light4 generations back · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K904518	Volumetric Infusion Pump	Kendall Mcgaw Laboratories, Inc.	1990	37
−4	K994375	Horizon Light	B.Braun Medical, Inc.	2000	Class I
−3	K011975	Horizon Outlook with Dosecom	B.Braun Medical, Inc.	2001	Class I
−2	K042121	Spectrum and Spectrum with Master Drug Library	Sigma Intl.	2004	Class I
−1	K123049	Sapphire Infusion Pump	Q Core Medical, Ltd.	2013	—
0 (this device)	K141834	Sapphire Administration Set	Q Core Medical, Ltd.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1996	1	0
2000	2	0
2002	1	0
2003	2	0
2004	1	0
2006	1	0
2008	1	0

FIG. 1 — Lineage of K141834, 1990–2014Source: 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.

3 devices in this family have 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

Get a 510(k) Report

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
*	K123049	Sapphire Infusion Pump Summary page 4 …FPA - Administration Sets Class II Predicate Device Q Core Administration Sets cleared under K123049 Administration Sets Bodyguard Infusion System sets with back check valve cleared unde…	Q Core Medical, Ltd.	2013	—
*	K031749	Bodyguard Infusion System Summary page 4 …inistration Sets cleared under K123049 Administration Sets Bodyguard Infusion System sets with back check valve cleared under K031749 Device Description The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for sin…	Caesarea Medical Electronics, Ltd.	2003	1

Also cleared against K123049: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 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.

K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K994375Horizon LightB.Braun Medical, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
9 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
4 other devices also cite its predicate K123049.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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 dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

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/K141834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141834: Sapphire Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141834

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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